Z-0698-2022 Class II Terminated
FDA device recall Z-0698-2022 was initiated by Microbiologics Inc on June 6, 2017 and is designated Class II. Reason for recall: Real-time shelf life testing failed at 24 months The recall status is terminated (terminated January 17, 2023). Affected quantity: 29 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2022
- Initiation Date
- June 6, 2017
- Termination Date
- January 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units
Product Description
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Reason for Recall
Real-time shelf life testing failed at 24 months
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.
Code Information
Catalog Number: 8193; Lot Number: 8193-04, 8193-06; UDI: 70845357041080