Abbott recalls i-STAT CG8+ cartridges that may show higher than expected calcium results when stored at room temperature for more than 3 days (lots *20100-*20339) or 7 days (lots *20340+).
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
Abbott is recalling i-STAT CG8+ cartridges that may give higher than expected calcium test results if stored at room temperature for more than 3 days (for certain lots) or 7 days (for other lots). This could lead to inaccurate test results if used after the storage period.
The cartridges may show higher than expected calcium results when stored at room temperature for longer than the specified time. This happens because the test results can become less accurate over time, especially if stored for more than the recommended period.
Users of Abbott i-STAT CG8+ cartridges for blood testing who store them at room temperature for more than 3 days (for lots *20100 to *20339) or 7 days (for lots *20340 and above) are affected. People using these cartridges for medical testing are most at risk of inaccurate results.
Check the lot number on the cartridge packaging. The lot numbers range from *20100 to *20339 (for storage up to 3 days) and *20340 and above (for storage up to 7 days). The * symbol represents lot letters A, K, L, M, N, W, or Y.
Verify if the cartridge has been stored at room temperature for more than the recommended time (3 days for lots *20100 to *20339 or 7 days for lots *20340 and above).
The cartridges may show higher than expected calcium results when stored at room temperature for more than 3 days (for certain lots) or 7 days (for other lots).
For lots *20100 to *20339, store for up to 3 days at room temperature. For lots *20340 and above, store for up to 7 days at room temperature.
Check if the cartridges have been stored for longer than the recommended time. If so, do not use them for testing.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0880-2021 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0880-2021 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.
