Recall Z-1096-2020 ยท OHQ Multi-Analyte Controls Unassayed
Microbiologics Inc
Vaginal Verification Panel Ref 8208 Lot 8208-11
| Date | Jan 3, 2020 |
| Status | Terminated |
| Reason | Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation. |
| Root cause | Process control |
| Action | Letters will be sent via email to all consignees and end users regarding the correction. Users are to review the instructions, determine how the information affects their usage, and upon determination either use with new information or discard the product. |
| Quantity | 9 |
| Distribution | Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.