FDA Device recall Z-1311-2024
Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis
- FDA Device
- Class II
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class II recall of Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis by Mckesson Medical Surgical Corporate Office, citing 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 D….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1311-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-09 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
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 .
Identifiers
| code_info | Catalogue Number: 184; Lot No. CK233; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Mckesson Medical Surgical Corporate Office recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1311-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.