Recall Z-1096-2020— Microbiologics Inc
Class II · Terminated
Class II FDA medical device recall by Microbiologics Inc, initiated 2020-01-03, terminated 2020-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Vaginal Verification Panel Ref 8208 Lot 8208-11. 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..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-03
- Terminated
- 2020-09-16
- Firm location
- Saint Cloud, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.