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

Recalled March 27, 2024 · FDA recall Z-1311-2024 · Mckesson Medical-Surgical Inc. Corporate Office

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 . · FDA Class II
Units
1 unit
Sold at
US Nationwide distribution in the states of AZ, PA and TX.

Description

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 .

Product
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
Manufacturer(s)
Mckesson Medical-Surgical Inc. Corporate Office

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

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