Z-1075-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2024
- Initiation Date
- January 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 580 packages
Product Description
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Reason for Recall
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.
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.
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.