Recall Z-1096-2020
Microbiologics Inc · initiated January 3, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vaginal Verification Panel Ref 8208 Lot 8208-11
Codes / lots: 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.
FDA-determined 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.
Details
- Recall number
- Z-1096-2020
- Initiated
- January 3, 2020
- Terminated
- September 16, 2020
- Product code
- OHQ – Multi-Analyte Controls Unassayed
- Quantity
- 9
- Distribution
- Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN