CHEM8 and CG4 Blue cartridge
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Abbott just posted a message about their blue chem 8 and cg4 cartridges not being FDA approved.
What will be your nexts steps?
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I also received a call from our Abbott sales representative notifying me about this situation. I am waiting for the official letter from Abbott, however, it appears that the company's recommendation is to notify this issue to the hospital units to stop testing immediately and pulled these two cartridges from all the shelves and fridges.
The company's notification letter is also supposed to approve the use of these two cartridges as a non-waived test, while they are waiting for the FDA approval of these two blue cartridges.
This problem will affect our emergency departments where they use the CG4+ cartridges primarily for Lactates to rule out sepsis.
Once, I receive the official letter, I am planning on discussing it with our lab medical directors and make the most appropriate decision. One will be exploring the possibility of continuing using the CG4+ as a non-waived (granted that this is what the official letter states), and the other will be to recommend the EDs to send a sample to the lab for Lactate testing.
As many of you, on last December we validated the new iSTAT CLEW software, and the CG4+ cartridges were able to provide results within the expected ranges for this particular upgrade.
Hope to hear more feedback from others regarding this issue.
I just got the letter today and I have to reread it and think before I really freak out! WTF!
The 2 notices (2nd notice includes G3 blue and mention of the discontinuance of ISTAT-6+, EC4, and E3 (all whites) can be found on the Abbott website under Product Alerts and notices. My Risk Management department actually received formal notification. Being a pediatric hospital, loss of capillary source will be a problem. We have been using the blues here for years ( I think since 2014). All of this and we are currently in a CAP inspection window-go figure.
Can someone send me the letter they received? Never mind I found it online.
Thank you.
Anastasia
it is posted on their website: https://www.pointofcare.abbott/us/en/alerts-notices
https://www.pointofcare.abbott/shared/static-assets/other/APOC2020-001%20CHEM8+%20CG4+%20capillary%20and%20CLIA%20notification%20letter%20FINAL.pdf
it is also on the Abbott website
If the cartridges are awaiting FDA approval wouldn't that make them LDTs and highly complex?
https://www.pointofcare.abbott/shared/static-assets/other/APOC2020-001 CHEM8+ CG4+ capillary and CLIA notification letter FINAL.pdf
https://www.pointofcare.abbott/shared/static-assets/other/2020 01 08 - APOC 2020-002 Discontinuation G3+ 6+ E3+ EC4+ letter final.pdf
Here are the links on both of the Abbott letters.
I'm not sure how to interpret this letter
"Currently the chem8 and CG4 cartridges are not FDA cleared and do not have CLIA waived status".
We only use as non-waived , but I think the "not FDA cleared" statement still applies?
Anybody know FDA guidelines? Can you use them if you place disclaimer notice?
Our Medical Director would like us to pull the cartridges mentioned immediately due to the risk factor stated in the letter.
It’s a mixed message but here is what I get.
Blue Chem 8+ “are not FDA cleared and do not have waived status” IF they are not FDA cleared they are “laboratory developed tests” so we have stringent performance
validation and high complex testing.
No capillary and no waived status – so both of those are gone for future options. But CHEM 8+ is in processs of FDA clearance for non-waived with arterial and
venous samples.
Should use alternate method if available
If not available – APOC will continue to send out and produce the BLUE while Abbot is working for FDA clearance for facilities in non-waived settings
If choose to continue use for arterial and venous only
should inform clinicians and lab staff that performance of these cartrdiges have not been fuly characterized.
Clinicans should be advised to consider patient signs, symptoms, history etc and if results do not match clinical presentation, the sample should be retested
using alternate method
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I called CAP.
CHEM8 and CG4+ are now considered High Complexity because they are not FDA cleared. In order to use them a laboratory must perform
Operators must have at least an associates degree. CAP is going to release a letter to address the issue a soon as possible.
That is what we feel, including our pathologists, and is the reason we pulled them from use immediately.
Jeremy Williford, PBT(ASCP)CM
Laboratory Services Coordinator
Laboratory
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South Georgia Medical Center
2501 North Patterson Street
Valdosta, Georgia 31602
229-433-4804 (O) | 229-563-2292 (M)
jeremy.williford@SGMC.ORG | sgmc.org
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