Class II

Medical Device Recall: Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis

Mckesson Medical-Surgical Inc. Corporate Office · January 9, 2024

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.

States Affected

NATIONWIDE

Quantity Affected

1 unit

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1311-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

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