Device product
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Z-1075-2024
Product summary
- Event
- Event 93801
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 580 packages
- Official record key
device-enforcement:Z-1075-2024
Official wording
Reason: The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.
Code information: Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448. UPDATE: The recall was expanded on 1/23/2024 to include the following additional lot numbers: 8184-65, exp. 3/31/2025; 8184-66, exp. 4/30/2025; 8184-67, exp. 5/31/2025; 8184-69, exp. 6/30/2025; 8184-70, exp. 8/31/2025; and 8184-71, exp. 8/31/2025.
Distribution pattern: US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY. There was government distribution and no military distribution. Foreign distribution was made to France.
Derived failure modes
-
Microbial contamination
contaminated with one of the positive control pathogens (Norovirus