Microbiologics Inc: Medical Device Recall in 2020 - (Recall #: Z-1096-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Vaginal Verification Panel Ref 8208 Lot 8208-11

Product Classification:

Class II

Date Initiated: January 3, 2020

Date Posted: February 12, 2020

Recall Number: Z-1096-2020

Event ID: 84634

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.

Status: Terminated

Product Quantity: 9

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.

Voluntary or Mandated:

Voluntary: Firm initiated