Vaginal Verification Panel Ref 8208 Lot 8208-11 — Class II medical device recall Z-1096-2020
Terminated recall by Microbiologics Inc, reported 2020-02-12, distributed in CA, KS, ME, NC, NY, OR, UT. Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcompo
| Recall number | Z-1096-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2020-01-03 |
| Classified | 2020-02-05 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2020-09-16 |
| Distributed | CA, KS, ME, NC, NY, OR, UT |
| Countries outside the US | CA, MX |
| Quantity | 9 |
| Lot numbers | 8208-11 |
| Model numbers | 8208 |
Product
Vaginal Verification Panel Ref 8208 Lot 8208-11
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1096-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.