Abbott iStat Cartridge Recall

[dingdong28]

Did you see the recall with Abbott's iStat blue cartridge recall? I think it mostly applies to capillary collection, but our hospital/system is disbanding the use of iStats until further notice to be on the safe side.

Abbott had a white cartridge for the iStat BMPs that were FDA approved and CLIA-waived before the blue cartridges. Abbott eventually made a modification to them which created the blue cartridge in 2015. Since then the blue cartridges were never FDA approved or CLIA-waived (even though Abbott stated otherwise) for testing because they weren't demonstrating well with ongoing studies, some facilities were performing poorly with 6 month correlations and Abbott didn't bother to seek FDA approval. Since they were used in clinical settings and were never really CLIA-waived, they've sent out this recall and CAP has already issued a memo that our chief pathologist received.

I'm not in charge of POCT, but have heard about this issue today from our POCT coordinator. Anybody else see this or dealing with this issue now? This (to me, at least) is like a really diluted version of what happened to Theranos.

I'd like to hear your thoughts on this.

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[Torsed]

Yep. Thanks Abbot. It affected our ionized calcium. Fortunately we do not have that many of them.

 

[LADoc00]

I didnt deal with it today as all hell was breaking loose on other fronts but thanks for this post because it reminds me what I need to tackle tomorrow morning!

 

[Ziehl-Neelsen]

Yeah. Our hospital uses the iStat a ton in the ED and NICU, and while the language in the recall was ambiguous, because we have "alternative testing methodologies" in the core lab, we decided to pull all the cartridges from these sites.

I don't think it's quite like Theranos since the white cartridges were FDA approved and CLIA waived, but it's incomprehensibly stupid for a clinical laboratory company to modify a component of a testing system and not run the equivalent of a validation/lot to lot between the 2 cartridges and submit it to the FDA for approval. Labs buy FDA approved tests because we don't want to go through the work of establishing LDT validations on every single freaking test--we're paying for the convenience of a vetted, scientifically valid test.

I'd love for an actual laboratory professional to get into the queue on the next quarterly conference call and ask Miles White for "some color" on the clowns they have managing their iStat program.

 

[chooks]

It's mind boggling how Abbot could let this happen. Someone there is truly gifted at being incompetent.

 

[Napoleon1801]

Did you see the recall with Abbott's iStat blue cartridge recall? I think it mostly applies to capillary collection, but our hospital/system is disbanding the use of iStats until further notice to be on the safe side.

Abbott had a white cartridge for the iStat BMPs that were FDA approved and CLIA-waived before the blue cartridges. Abbott eventually made a modification to them which created the blue cartridge in 2015. Since then the blue cartridges were never FDA approved or CLIA-waived (even though Abbott stated otherwise) for testing because they weren't demonstrating well with ongoing studies, some facilities were performing poorly with 6 month correlations and Abbott didn't bother to seek FDA approval. Since they were used in clinical settings and were never really CLIA-waived, they've sent out this recall and CAP has already issued a memo that our chief pathologist received.

I'm not in charge of POCT, but have heard about this issue today from our POCT coordinator. Anybody else see this or dealing with this issue now? This (to me, at least) is like a really diluted version of what happened to Theranos.

I'd like to hear your thoughts on this.

Perhaps it's a mixed blessing? Istats are pricey to run, so it does allow us to consolidate most of this volume back to our core lab. However, the lactic acids are necessitating a tighter process when the traumas come in. We may look at Nova if this situation persists.

Abbott seems to have a history of dropping the ball.

 

[dingdong28]

Perhaps it's a mixed blessing? Istats are pricey to run, so it does allow us to consolidate most of this volume back to our core lab. However, the lactic acids are necessitating a tighter process when the traumas come in. We may look at Nova if this situation persists.

Abbott seems to have a history of dropping the ball.

How pricey are they? Well, more like how pricey were they 😉. I never bothered to look into the price of running one. We're going to run into issues with BMPs and ionized calciums. Now we have to wait for them to order each test, which you can only imagine how that's going to go.

I think our chief pathologist looked into switching to Nova as well. She was pushing for more Gems (Instrumentation Laboratory), but didn't realize how long it would take and expensive it would be. I was wondering if Abbott's stock would drop after this incident, but it's actually increased albeit by a few cents.

 

[Ziehl-Neelsen]

That was quick.