Vaginal Verification Panel Ref 8208 Lot 8208-11
- Company
- Microbiologics Inc
- Recall Initiated
- January 3, 2020
- Terminated
- September 16, 2020
- Recall Number
- Z-1096-2020
- Quantity
- 9
- Firm Location
- Saint Cloud, MN
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.
Lot / Code Info
Lot 8208-11
Root Cause
Process control
Action Taken
Letters will be sent via email to all consignees and end users regarding the correction. Users are to review the instructions, determine how the information affects their usage, and upon determination either use with new information or discard the product.