Recall Z-1075-2024 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
| Date | Feb 12, 2024 (initiated Jan 8, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.