Recall Z-0784-2022 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Mycoplasma genitalium Control Panel (Inactivated Pellet)
| Date | Feb 25, 2022 |
| Status | Terminated |
| Reason | Distributed product did not undergo proper release testing. |
| Root cause | Nonconforming Material/Component |
| Action | All consignees were contacted beginning 02/25/2022 via email. Consignees should read the recall instructions and determine if the product can be used or discarded, depending on user's lab procedures. A response form should be completed and returned to recall@microbiologics.com. |
| Quantity | 80 units |
| Distribution | Distribution in US: AZ, CT, DC, FL, IL, IN, KS, KY, MA, MD, NC, NH, NJ, NY, PA, TX, UT, WA OUS distribution to Belgium, Finland, France, Germany, Ireland, Sweden, United Kingdom, and Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.