# FDA recall Z-1096-2020

> **Microbiologics Inc** · Class II · device recall initiated 2020-01-03.

## 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.

## Distribution

Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT.  No Canada, Mexico or VA.

## Key facts

- **Recall number:** Z-1096-2020
- **Recalling firm:** Microbiologics Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-03
- **Report date:** 2020-02-12
- **Termination date:** 2020-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Cloud, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1096-2020

## Citation

> AI Analytics. FDA recall Z-1096-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1096-2020. Source: US FDA. Licensed CC0.

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