Where did VM go?

RC, the architect of the Troponin Burning Platform, sits unscathed as he now directs the demise of DxN.

Danaher is eradicating bad blood that caused troponin (Med officer PH) (Marketing LF) (Regulatory COD, VM) (Pro Mgemnt NoOne?). Why does RC remain?

FDA does not allow Beckman to sell any Troponin to any new (non-Beckman)hospital today. FDA DID allow Beckman to grand-father in hospitals that use the access. Having said that, if the same existing hospital bought a new access, and traded-in their old one, they would not be allowed to run Troponin on the new one...

Weird rules...The FDA decision makes no sense, but I'm sure the FDA negotiated this all out with Beckman.

Yes, this IS a new troponin.

+++++
If it really is a NEW troponin then why did FDA only stop sales of troponin reagent on the DxI and not the Access/Access 2 since the reagent cartridges are the same?

Yes, this IS a new troponin. That's the whole reason why it was taken off the market. Beckman changed the formula without notifying the FDA. The FDA found out and warned Beckman not to do it again. Then the FDA told Beckman to perform all necessary studies for this new Troponin, in which Beckman is going through this process now. The Beckman folks are saying, "this is not a new Troponin", but in the FDA's eyes, (and Rest-of-World), it certainly is.

The TnI in 2012 or 2013 and Vit D in 2013 or 2014 can be but it is not certain because it is beckman.

Interesting strawman. This isn't a new troponin.

The FDA is trying to figure out how best standardize troponins. With 18 different ones on the market, all giving different numbers, this is going to be difficult. Knowing this is job one for troponin, and knowing this is going to take considerable time, I don't see the FDA releasing any new troponins, from any vendor, for quite some time.

"All my lab. wants is to know when the problem will be fixed not internal problems or crap about paper shuffling"

Good Luck with that! The message here is that anyone who might actually be working to fix the problem is spending the majority of their time shuffling paper to make Danaher happy. Not what you want to hear, but true none the less!

Submitted by Anonymous on Fri, 09/12/2011 - 16:59.
[This pretty much sums up what is going on everywhere at BCI these days.]

And after the reports are complete, they're sent out for 3rd party review to a horde of non-experts who ask irrelevant questions that need another 6 hours to answer.

All my lab. wants is to know when the problem will be fixed not internal problems or crap about paper shuffling

Troponin and all new development... Where is vitamin D? Nothing new under the radar. And danaher is too greedy to fix this.

LC and TJ looked good at first now everybody know they just want to maintain their lifestyle.

[This pretty much sums up what is going on everywhere at BCI these days.]

And after the reports are complete, they're sent out for 3rd party review to a horde of non-experts who ask irrelevant questions that need another 6 hours to answer.

"Danaher is closely monitoring the situation.

Every morning they send out a dozen more spreadsheets to be updated before the end of business. Each spreadsheet requires everyone working on the troponin to stop what they are doing and spend 6 hours filling in the new cells that are slightly different than the cells in the spreadsheet the day before."

This pretty much sums up what is going on everywhere at BCI these days.

Danaher is closely monitoring the situation.

Every morning they send out a dozen more spreadsheets to be updated before the end of business. Each spreadsheet requires everyone working on the troponin to stop what they are doing and spend 6 hours filling in the new cells that are slightly different than the cells in the spreadsheet the day before.

Overnight, the spreasheets are send to India to be summarized so that a report is ready for LC when he wakes up.

Fix it, run your stored samples, submit a 510k, end of story.

====
Precisely.

"Blamming RC for the troponin-I problem at D-BCI is similar to blamming the weatherman for the snowstorm."

Sycophant. Is Richard dictating over your shoulder?

"Blamming RC for the troponin-I problem at D-BCI is similar to blamming the weatherman for the snowstorm."

No, it's similar to blaming BP/Halliburton for the Burning Platform in the Gulf of Mexico. Direct cause and effect in each case.

So, "evil guv'mint" is the problem? Is Faux news handling beckdanaher's PR now? Fix it, run your stored samples, submit a 510k, end of story. No one is getting a plush retirement out of regulating a minor product from some also-ran company. If you can't fix it just OEM it from somebody willing to invest in the kind of people that can.

[Blamming RC for the troponin-I problem at D-BCI is similar to blamming the weatherman for the snowstorm.]

Huh?? If this is how BEC employees communicate (and spell) it is no wonder why they are in trouble.

Blamming RC for the troponin-I problem at D-BCI is similar to blamming the weatherman for the snowstorm. The cause is not
what ya'll in the proletariot would like to think it is. The fix
is fairly straight forward if the poltroons in the FDA would allow
it. Remember that bureaucrats, i.e the FDA, have the following goals: maximaize their salaries, maximize their retirement benefits, appear to be doing something useful and lastly addressing actual or perceived issues.

The cause of the troponin problem is known and is a common one in this kind of assay. Experienced and educated scientists that have been around the block a few times have solved it before and will solve it again but for some other company. The glorified lab techs at bec will still be banging the rocks together and making powerpoint slides about it when management announces they're OEMing.

I knew JB had the same persona -- slightly better bedside manner but evil none-the-less.

RC drove out most of the experienced scientists with his abusive "I-know-everything-and-you-are-my-ignorant-slaves" behavior. Current staff is inexperienced and baffled.

Dahaher is falling for RC's self-aggrandizement.

JB has taken on RC's behavior.

When will the new R&D VP Helmut K wrest control from this deranged and oblivious ship of fools?