Recall Z-1075-2024
Microbiologics Inc · initiated January 8, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Codes / lots: 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.
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.
FDA-determined cause: Process control
Action taken
The recalling firm issued letters dated 1/8/2024 beginning 1/8/2024 informing the consignee of the issue and providing the following instructions: (1) Review lab procedures to understand how this information affects your usage; (2) Use or discard depending on your lab procedures and how this information affects your usage; (3) Complete the response form provided; (4) Return the response form to the firm; (5) keep the letter for your records; and (6) contact Microbiologics if a replacement kit is needed. On 1/25/2024, the firm issued letters dated 1/24/2024 via email to notify consignees they have expanded the recall to include additional lot numbers. Other than providing additional lot numbers, the letter was the same as the initial letter issued on 1/8/2024. The firm reported the email that had the letter attached alerted the consignee that the recall was expanded to include additional lot numbers.
Details
- Recall number
- Z-1075-2024
- Initiated
- January 8, 2024
- Posted by FDA
- February 12, 2024
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 580 packages
- Distribution
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN