Mckesson Medical-Surgical Inc. Corporate Office: Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of AZ, PA and TX. Quantity: 1 unit Lot/code info: Catalogue Number: 06F1201; UDI/DI: 54749000463; Lot No: 101164

UPC codes

54749000463

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.