Abbott recalls i-STAT Level 1 test kits that may have been stored in refrigerators with temperature issues, potentially causing incorrect or delayed test results. Affected kits were sold in specific lots and may require replacement.
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Abbott is recalling i-STAT Level 1 test kits that could have been stored in refrigerators with temperature problems. This might lead to incorrect or delayed test results if the kits were exposed to temperatures outside the safe range for up to 60 minutes.
The test kits could have been stored in walk-in refrigerators that experienced mechanical failures on January 8, 2024. This caused temperatures to drop below 35.6°F (2°C) for up to 60 minutes, which might lead to incorrect or delayed test results.
Healthcare facilities using Abbott i-STAT Level 1 test kits with specific lot numbers are likely affected. Staff handling these kits may be at risk if temperature issues occurred.
Check for the product name 'Abbott i-STAT Level 1 10 X 1.7 mL' with lot number 101164. The kits were sold with specific catalog numbers and UDI/DI codes.
Review refrigerator logs for temperature excursions below 35.6°F (2°C) around January 8, 2024.
Lot number 101164.
Check for the lot number 101164 on the kit's label or documentation.
The recall does not specify an immediate replacement requirement; check temperature logs for affected kits.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1314-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1314-2024 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.
