Recall Z-1311-2024— Mckesson Medical-Surgical Inc. Corporate Office
Class II · Ongoing
Class II FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2024-01-09. It names one FDA 510(k) clearance: K050755. Product: Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis. 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 ..
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-09
- Firm location
- Richmond, VA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
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 .
Data sourced from openFDA. This site is unofficial and independent of the FDA.