Anyone have any insights on this issue?
Will it be resolved quickly or spiral into a recall/withdrawal like we saw with Troponin?
Beckman Alert for Synchron Glucose Reagent - readings may be higher than reported so recommendation to use alternate methods
Submitted by Anonymous on Fri, 23/04/2010 - 18:17

Who was COD? ==== 1. Remember
Who was COD?
====
1. Remember that this is a rumor board, there may be no substance to the rumor that COD is leaving. There have been many rumors of this before.
2. Biofind rules prohibit using names here so we cannot use COD's full name.
3. If you are or were a Beckman employee you should know the names of your site and corporate management (granted it's been in a state of flux for some time.)
4. If you really want to know who COD is go to the Beckman web site and locate the management section. All the VP's photos and bios are there. You should be able to figure it out.
Who was COD?
Who was COD?
Goodbye COD you will not be
Goodbye COD
you will not be missed.
Your desicions from the past finally caught up to you.
Bye Bye
COD will be gone before the
COD will be gone before the end of this month
###
Watch them bring in a new quality/regulatory VP from Danaher. Someone who knows nothing about diagnostics or FDA regs.
While I'm certainly glad to be out of Beckman and away from the arrogant, self-serving, back-stabbing folks that caused Beckman's decline, I almost feel sorry for those who remain.
"COD will be gone before the
"COD will be gone before the end of this month"
It will take more than that to solve Beckman's quality & regulatory woes.
COD will be gone before the
COD will be gone before the end of this month
You can also find some great
You can also find some great aftermarket reagent companies out there that can save you money with better results. Be careful because there are also some bad ones.
Long ago I worked for Beckman
Long ago I worked for Beckman and I can tell you that they have been headed this way for quite some time. I started my own manufacturing company in 1987 after leaving Beckman. This is a shamless plug, but I feel it applies perfectly here. If you are looking for support/parts/consumables for Beckman Synchron lines or the Olympus AU check us out at www.buypvi.com.
moot point, moot point, moot
moot point,
moot point,
moot point,
moot point,
.
.
.
Sigh...
A mute point now?
A mute point now?
Did those of you who
Did those of you who terminated the contract early ever hear any response or attempts by Beckman to get paid for the remainder of the term?
Lucky SOB's, instead of being
Lucky SOB's, instead of being neutered, and in the dog house, BCI is now leading the pack by 6 months in clinical trials and re-validation.
+++
Guess I don't see Beckman leading the pack as they are unable to sell troponin during the clinical trials and recertification efforts. In addition they have a black eye now with customers, investors and FDA. Meanwhile the other manufacturers can perform clinical trials pretty much at their leisure while still being able to sell product.
Don't get too cocky about
Don't get too cocky about Beckman quite yet. FDA is not done and troponin 510(k) is potentially up to 14 months away. Remember Beckman made changes without FDA knowledge or approval while none of the other manufacturers have been accused of that. Certainly there will be some type of penalty assessed.
Beckman still has numerous law firms sniffing around regarding fiduciary responsibility of management. Investors won't rest easy until Beckman can demonstrate a clear trend towards quality, ethics, patient safety and customer satisfaction. The same management team that brought you this mess (minus SG) is still in place. Announcing a new CEO would be huge.
As good a news as this is to
As good a news as this is to stock holders like me, I think more interesting is that the FDA has sent letters to all manufacturers of Troponin test kits basically saying "Call us" to review their 501K and clinical trials. All manufacturers may have to perform 510K and clinical trials to the new FDA Guidelines, as BCI is doing now. Lucky SOB's, instead of being neutered, and in the dog house, BCI is now leading the pack by 6 months in clinical trials and re-validation. Nothing like a spin of this magnitude to leave jaws gaping.
Morgan Stanley Said Early
Morgan Stanley Said Early Evidence Of Progress With The FDA Was Most Significant Positive For Beckman Coulter During Quarter
Written on Thu, 10/28/2010 - 12:06pm
"Morgan Stanley said early evidence of progress with the FDA on multiple product quality issues was the most significant positive in the quarter for Beckman Coulter (NYSE:BEC), in its view, with the first new product approval of 2010 a non-510(k)-dependent solution for glucose and a near term 510(k) filing for sodium.
Analysts Marshall Urist, David Lewis and Neha Sahni said, "3Q was ahead of expectations on both the top and bottom lines, and the market is likely to take some comfort in ~1% net customer losses sequentially. However, visibility on the customer impact of quality issues is limited and the US commercial trough still lies ahead, in our view, as more purchasing cycles begin to capture Beckman's quality issues."
New recall coming soon, not a
New recall coming soon, not a surprise anymore
DxC is a dead end, everybody
DxC is a dead end, everybody knows it
Beckman were a marvellous
Beckman were a marvellous company until about 15 years ago when they decided that the revenue stream from diagnostics was much more appealing than the more erratic one from instrument sales.
I don't think Beckman can
I don't think Beckman can recover from this. They have "lost" too many talented people that knew what they were doing. The people left are from the "Mud Hut" countries like Vietnam, not paid much, easy to manage.
The root cause of the problem
The root cause of the problem is not resolved.
Typical Beckman. Lets just try a "Band Aid" to fix the problem.
"Fix it in the field". "Customer won't Notice" "It's never been a problem before".
Beckman is the worst Company I have ever come across. They deserve to be in the place where they are at.
For the ISE fix, all they are
For the ISE fix, all they are going to do is replace a worn pump in the ISE with the same pump but new.
This hypocracy is lead by GB and WP. They know it won't fix anything. They want to give the impression that they are doing something about it. The root cause of the problem is not resolved.
Another $5.0 M down the drain. Way to go GB and WP. Two stooges trying to outstage one another. No leadership , no vision, no way out of the Abyss.
Typical Beckman "Band Aid"
Typical Beckman "Band Aid" fox. I'm sure this was approved by Senior VP of Quality, She does not know a thing about the business.
For the ISE fix, all they are
For the ISE fix, all they are going to do is replace a worn pump in the ISE with the same pump but new. No design change at all. Total ass holes. How does that get rid of the problem. It will only show up again once the pump wears out.
They have known about the ISE
They have known about the ISE & Glucose problems for 5 years now and have done nothing to correct it. Now the FDA is holding their feet to the fire.
This one is just about to be
This one is just about to be announced....Should come as no surprise who gets canned.
Management needs a few "Fall
Management needs a few "Fall guys" for the FDA...
Should see this this week, about time too
[Management needs a few "Fall
[Management needs a few "Fall guys" for the FDA...]
While I agree that presenting the illusion that Regulatory is fixed and on the job might be beneficial for FDA and even investor purposes, the fact remains that BEC still has significant technical issues to resolve. Regulatory is the cop or gatekeeper not the technical expert. I seriously doubt that the Beckman technical experts who remain after all the layoffs have the knowledge or understanding to solve the issues.
"COD will be gone before the
"COD will be gone before the end of this month, that's what I've heard"
Will EB be gone also?
COD will be gone before the
COD will be gone before the end of this month, that's what I've heard
CAD has no credible value
CAD has no credible value anymore, I doubt if she will be there for more than a few weeks, Management needs a few "Fall guys" for the FDA
and she is top of the list.
COD has no chance of fixing
COD has no chance of fixing the Glucose issue, by the looks of her she should spend less time at the "Junk Food" fast food places and more time attempting to resolve the issues before she gets blamed for the whole disgusting situation.
If she took her job seriously, there would be not many left in her department.
"More glucose issues this
"More glucose issues this week. What other "alternate" method can they put on customers now? They have exhausted both of theirs with "no known root cause" of the problem. Come on FDA! Do something about all the negligence!"
You can b*tch here on Biofind and it actually might make you feel better (but it won't solve the problem) or you can file a report with the FDA on MedWatch.
Access FDA MedWatch here:
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
There was a Creatine PCA out
There was a Creatine PCA out today too.
The saga continues.
one letter from legal? can
one letter from legal? can you share what hospital you are at?? we would like to do the same.
There are no problems with
There are no problems with glucose test, shut up and just sign the reagent contract,
SG
More glucose issues this
More glucose issues this week. What other "alternate" method can they put on customers now?
They have exhausted both of theirs with "no known root cause" of the problem. Come on FDA! Do something about all the negligence!
Hello. impressive job. I did
Hello. impressive job. I did not expect this. This is a impressive story. Thanks!
We got rid of their Equipment
We got rid of their Equipment months ago, one letter from our Legal department did it. No response from Beckman Coulter.
Break the contract due to
Break the contract due to wrong results. Send it to your legal department just like we did and dumpted their useless Instruments out of our Lab.
There was no response from Beckman......Wonder Why????
+++++++++++++++++++++++++++++++++++++++++++++++++++
No response at all from Beckman? Not surprising, we haven't been able to get a response from anybody about our issues for sometime now. SHOCKING!! Do you have to pay the remainder of your agreement?
What is the reason to keep
What is the reason to keep Beckman Coulter equipment any more???
Are you tied in to a reagent contract?
Break the contract due to wrong results. Send it to your legal department just like we did and dumpted their useless Instruments out of our Lab.
There was no response from Beckman......Wonder Why????
How about phenobarbs?
How about phenobarbs? Anybody else having trouble with them? Seems like it's a never-ending battle with them.
Are total proteins running
Are total proteins running low?
**********************************
We have had problems with TPs for almost a year now and tech support and the folks at Beckman adamantly DENY any problems or that anybody else had reported any problems with the test!
The total proteins report out values less than your albumin. Of course Beckman can't see a problem with that. What I can tell you is that when you get to about 50 tests left on the pack, PITCH it. Seems to work. AND get rid of them if you can, same problems here.
Are total proteins running
Are total proteins running low? We also have a problem with low total proteins but haven't verified problem yet. We have DxC600i and Dxi680 instruments and are having lots of low sodiums, have already switched from cartridge glucoses to MC glucoses, troponins down on 680i because of FDA recall. Not sure where to start or how to compensate for all the problems we are encountering. Service is giving us the run around...imagine that...lol.
COD is gone, she was way out
COD is gone, she was way out of her league anyway
Are you sure, I have a meeting next week with her
look out for more recall
look out for more recall announcements in June, more bad news.
Looks like the Beckman ship is sinking. Scott is going to rearrange
the deckchairs on the Titanic, ha ha ha
COD is gone, she was way out of her league anyway
COD is gone for Sure, She
COD is gone for Sure, She received some bad publicity and was not long in the job, besides the fact, who could understand her anyway with that accent???????????
She's gone.........
how about some substance to
how about some substance to these charges?
I'm not defending COD, don't
I'm not defending COD, don't even know her. I do know that she is not the first VP of Quality/Regulatory during SG's reign. Scotty hand picked her and those in the position before. There comes a time when you have to question his decision making ability. Maybe it is time to quit making employees scapegoats and start holding SG accountable.
COD is on vacation this week.
COD is on vacation this week. Maybe it will be permanent?
COD is gone for Sure, She
COD is gone for Sure, She received some bad publicity and was not long in the job, besides the fact, who could understand her anyway with that accent???????????
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