Microbiologics Inc recalls Vaginal Verification Panel Ref 8208 Lot 8208-11

Recall date

January 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1096-2020

FDA classification

Class II

Brand / firm

Microbiologics Inc

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vaginal Verification Panel Ref 8208 Lot 8208-11