FDA Device recall Z-1096-2020
Vaginal Verification Panel Ref 8208 Lot 8208-11
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of Vaginal Verification Panel Ref 8208 Lot 8208-11 by Microbiologics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1096-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-03 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Microbiologics |
| Distribution | CA, KS, ME, NC, NY, OR, UT, VA |
Product
Vaginal Verification Panel Ref 8208 Lot 8208-11
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.
Identifiers
| code_info | Lot 8208-11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.