Abbott recalls i-STAT cTnI blue cartridges that may generate 3-5% quality check errors. Affected units sold with specific list numbers. Consumers should check their cartridges for the listed identifiers.
i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
Abbott is recalling i-STAT cTnI blue cartridges that may produce 3-5% more quality check errors than expected. This could lead to inaccurate test results if the cartridges are used without proper validation.
The cartridges may generate a higher number of quality check codes, which could indicate inaccurate test results. This rate of 3-5% is higher than expected but does not pose a direct safety risk to users.
Users of the i-STAT cTnI blue cartridges for blood testing are likely affected. Those who have the specific list number 06P23-25 and UDI (01)00054749001986 are most at risk.
Check for the list number 06P23-25 and unique device identifier (UDI) (01)00054749001986 on the cartridge packaging or label.
Look for the list number 06P23-25 and UDI (01)00054749001986 on the cartridge packaging or label.
The recall is for potential inaccurate test results, not a safety hazard. There is no risk of injury or death.
Check for the list number 06P23-25 and UDI (01)00054749001986 on the cartridge packaging or label.
The recall does not specify a remedy, so you can continue using the cartridges if they are functioning properly.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0761-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0761-2020 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
