Skip to content
Recall Observatory FDA recall evidence

Device product

Vaginal Verification Panel Ref 8208 Lot 8208-11

Z-1096-2020

January 03, 2020

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 84634
Status
Terminated
Classification
Class II
Quantity
9
Official record key
device-enforcement:Z-1096-2020

Official wording

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.

Code information: Lot 8208-11

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.