Sekisui Diagnostics Control Kit OSOM BVBLUE Bacterial Vaginosis
FDA device recall Z-1311-2024 · posted 2024-03-19 · Open, Classified
Recall details
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- 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 .
- Action taken
- McKesson notified customers by phone January 9, 2024 with a follow-up call January 17, 2024 instructing customers of three scenarios based upon the products they received and the investigation in conjunction with relevant manufacturer. The firm also sent Urgent Product Recall Notifications via email on February 8, 2024 instructing customers to immediately examine inventory and quarantine all affected devices, complete and return the provided response form to MMSQRCProductReviews@Mckesson.com, and notify customers who you have further distributed recalled devices to of this recall and to segregate and quarantine any devices they have on hand. Replacement products will be provided and may have the same lot number(s) as the recalled items but are not affected by the recall and are acceptable for use. Customers with questions can contact McKesson directly by phone at (800) 688-8840. Representatives are available Monday to Friday, 8:00 am to 5:00 pm PST.
- Root cause
- Storage
- Status
- Open, Classified
- Product code
- MXB
- Quantity affected
- 1 unit
- Distribution
- US Nationwide distribution in the states of AZ, PA and TX.
- Date initiated
- 2024-01-09
- Date posted
- 2024-03-19
- Location
- Richmond, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BVBLUE (K050755) | Gryphus Diagnostics, LLC | 2005-04-06 |