Recall Z-0844-2022 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria
| Date | Mar 3, 2022 |
| Status | Terminated |
| Reason | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. |
| Root cause | Incorrect or no expiration date |
| Action | Microbiologics notified customers on 03/03/2022 via letter titled "Urgent Medical Device Recall Re: 8244 Pneumonia (33 Targets) Control Panel". Instructions included to review lab procedures to understand how the information affects usage, discard expired product, complete the response form provided, return the response form to recall@microbiologics.com, and keep the letter for consignees' records. Questions or concerns can be directed to the Recall Support team at 320.229.7073 or recall@microbiologics.com. |
| Quantity | 13 units |
| Distribution | US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.