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Recall Observatory FDA recall evidence

Device product

Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

Z-1314-2024

January 09, 2024

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 94024
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-1314-2024

Official wording

Reason: 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.

Code information: Catalogue Number: 06F1201; UDI/DI: 54749000463; Lot No: 101164

Distribution pattern: US Nationwide distribution in the states of AZ, PA and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.