Abbott recalls i-STAT Level 3 1.7mL test kits that may have experienced temperature excursions in walk-in refrigerators, potentially causing incorrect or delayed test results. Affected units were sold from January 2024.
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 3 1.7 mL test kits that may have been stored in walk-in refrigerators with temperature issues. This could lead to incorrect or delayed test results if the kits were used after the temperature excursion.
The test kits may have been stored in walk-in refrigerators with temperatures falling below 35.6°F (2°C) for up to 60 minutes. This could cause the test results to be incorrect or delayed, but the risk is limited to facilities that experienced the temperature issue.
Healthcare facilities that purchased these test kits from January 2024. Staff using the kits for patient testing are most at risk if the temperature issues occurred.
Check for the product name 'i-STAT Level 3 1.7 mL' with catalogue number 06F1401. These kits were sold starting in January 2024.
Review refrigeration logs for temperature excursions below 35.6°F (2°C) between January 2024 and the current date.
The test kits may have been stored in walk-in refrigerators with temperatures falling below 35.6°F (2°C) for up to 60 minutes, which could cause incorrect or delayed test results.
Look for the product name 'i-STAT Level 3 1.7 mL' with catalogue number 06F1401. These kits were sold starting in January 2024.
Review refrigeration logs for temperature excursions below 35.6°F (2°C) between January 2024 and now. No immediate action is required if no issues were found.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1315-2024 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1315-2024 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.
