FDA recall Z-1096-2020

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

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

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