Device product
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Z-0698-2022
Product summary
- Event
- Event 89446
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 units
- Official record key
device-enforcement:Z-0698-2022
Official wording
Reason: Real-time shelf life testing failed at 24 months
Code information: Catalog Number: 8193; Lot Number: 8193-04, 8193-06; UDI: 70845357041080
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
Derived failure modes
-
Unknown
Real-time shelf life testing failed at 24 months