Device product
BD BBL TB Stain Kit K, Catalog (REF): 212522
Z-1296-2025
Product summary
- Event
- Event 96244
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 247 units
- Official record key
device-enforcement:Z-1296-2025
Official wording
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.
Code information: Catalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;
Distribution pattern: Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.
Derived failure modes
-
Unknown
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.