Z-1096-2020 Class II Terminated
FDA device recall Z-1096-2020 was initiated by Microbiologics Inc on January 3, 2020 and is designated Class II. 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. … The recall status is terminated (terminated September 16, 2020). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- January 3, 2020
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
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 Pattern
Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
Code Information
Lot 8208-11