What's funny is my Beckman chemistry rep is acting like all is normal, nothing is wrong. Life is a bowl of cherries....paraphrasing a few statements:

"Look at these pictures of my kids.

Beckman is having a record setting sales year.

Don't worry about Troponin, we've found ways around that...we'll just sell you a DXC600i for your Troponin. The FDA didn't mention we can't do that. And, we'll swap it out for a different system later.

The FDA is looking at everyone's Troponin, in fact, Beckman is further along in the studies than any other vendor. This is not a Beckman issue, it's just a simple FDA review of all Troponins... The FDA will give us the "all clear" call very soon...

You don't really have to put the disclaimer statements on the ISE tests, many labs don't do it, so why should you?

Not worth the risk of going with anything Beckman. We dumped them.

With so much negativity toward Beckman, (Troponin, ISE's, Glucose, HCG, For-Sale sign in front yard, Quality department deserted, FDA audits & warning letters),... I'm wondering if this company can survive.

My guess, it will be broken up into pieces and sold off. Beckman is dead.

Submitted by Anonymous on Sat, 11/12/2010 - 14:09.
As a Lab Manager in the US, you need to ask yourself why would you take a chance on this. With ISE problems, glucose problems, HCG (falsely elevated results Nov-2010 BCI letter), and now Troponin problems (with known false positives), and now, Beckman just put themselves up for sale...

You're taking an abnormally high risk to your patients, your physician relationships, and your lab.
Does any one think that Beckman cares any more they deserve all they are going to get however the board do not deserve the golden handshakes they will get do you remember Garrett received an extra phenomenal bonus for all the hard work he did to achieve the purchase of Olympus.

As a Lab Manager in the US, you need to ask yourself why would you take a chance on this. With ISE problems, glucose problems, HCG (falsely elevated results Nov-2010 BCI letter), and now Troponin problems (with known false positives), and now, Beckman just put themselves up for sale...

You're taking an abnormally high risk to your patients, your physician relationships, and your lab.

The web site is global. FDA only USA. Troponin available on all systems outside USA. Inside TnI can be run on Access, not DxI.
One issue was different results on DxI from Access, sometimes.
Outside USA and TnI is still run, but labs much more careful about false positives.

Definitely "paper tiger". Beckman reps are still actively selling Troponin, not even mentioning this. Check the Beckman website, troponin still listed as available on all their immuno systems.

It is if it still allows Beckman's Troponin to stay on the market to existing customers.
Either it is OK and can be sold to all. Or it isn't and it is off the market. No exceptions.
FDA is not even a paper tiger in this case. A pussy without any claws?

[Can't remember any other situation where the FDA was such a paper tiger.]

Does not seem like sending Beckman a warning letter and requiring them to perform new clinical studies and obtain new Troponin certification is a "paper tiger" enforcement action.

Sounds like Beckman was extremely lucky. Can't remember any other situation where the FDA was such a paper tiger.

"Sounds like a weird loop-hole...."

It is wierd and FDA really should have banned all Beckman Troponin sales pending recertification. Since FDA did not and some customers are still able to order Troponin reagent nothing would keep them from using the reagent on any Access instrument in their lab. It's different for DxI where service has installed a software lock on the DxI instruments to prevent running Troponins.

Beckman received a huge break from FDA. They really should have been spanked for the Troponin shenanigans.

Yes use Beckman Troponin test, if you want wrong answers and let patients die.

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The problem is a false positive not a false negative. Still a negative effect on the patient but it is the risk of unneeded treatment not the risk of not being treated.

Sounds like a weird loop-hole.... So, if existing BCI customer, then can place new BCI system w/ Troponin. If BCI is new to the lab, then no BCI Troponin can be performed. Can't imagine that the FDA approved such a weird split. ...Kind of like the FDA is saying we know it's bad, but if you're already experiencing bad, you can continue to experience bad...if you haven't experienced bad yet, then we don't want you to experience bad...

Really?

if your buying them, why do you not ask the sales rep?

Yes use Beckman Troponin test, if you want wrong answers and let patients die.
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So, where has this happened again?

Since this is an integrated system (DXC600i) using a Beckman DXC600 and an Access2 connected with a CTA (Closed Tube Aliquoter), and you already do not have a current installed Access in your lab, then the answer is NO. If you are already an Access user, then you should be able to run them on the DXC600i.

Yes use Beckman Troponin test, if you want wrong answers and let patients die.

So....on what integrated systems can Beckman sell Troponin today?
Signed...confused original poster. ps...Beckman rep hasn't mentioned any of this, colleague at another hospital did...

Perhaps Beckman has a program to offer you an alternative Troponin instrument if you purchased the DxC600i's. Of course that would be a real headache probably not worth investigating. After all there is no assurance that Beckman will get FDA release for Troponin.

Beckman made their mess and now they can wallow in it.

Troponin I is only available to the already installed base with Access/Access2/DXC600i/LXi

The FDA prohibits BCI from selling troponin on new installations of Access or DXC600i instruments.