Recall Z-1296-2025 ยท JTS Stains, Microbiologic
Becton Dickinson & Co.
BD BBL TB Stain Kit K, Catalog (REF): 212522
| Date | Mar 6, 2025 (initiated Feb 12, 2025) |
| Status | Open, Classified |
| Reason | One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025. |
| Root cause | Under Investigation by firm |
| Action | On February 12, 2025 URGENT: MEDICAL DEVICE PRODUCT REMOVAL letters were sent to distributors. Please Take the Following Actions: 1. Immediately inspect your inventory for the specific catalog and lot number listed to determine if the lot in your possession are impacted and immediately discard any remaining inventory of the affected product. 2. Ensure the contents of this notification are read and understood. 3. Identify all customers within your distribution network that purchased any affected product as defined in this Product Recall. Provide a copy of the attached customer letter to all cus |
| Quantity | 247 units |
| Distribution | Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.