Mckesson Medical-Surgical Inc. Corporate Office: Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis

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 .

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 . Distribution: US Nationwide distribution in the states of AZ, PA and TX. Quantity: 1 unit Lot/code info: Catalogue Number: 184; Lot No. CK233;

Source

Official record: FDA (Device enforcement) ↗

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