Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Vaginal Verification Panel Ref 8208 Lot 8208-11 Recalled by Microbiologics Inc Due to Product 8208 Vaginal Verification Panel is a 6...

Date: January 3, 2020
Company: Microbiologics Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Microbiologics Inc directly.

Affected Products

Vaginal Verification Panel Ref 8208 Lot 8208-11

Quantity: 9

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 8 states: CA, KS, ME, NY, NC, OR, UT, VA

Affected (8 states)Not affected

About Microbiologics Inc

Microbiologics Inc has 66 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report