Vaginal Verification Panel Ref 8208 Lot 8208-11
Reported: February 12, 2020 Initiated: January 3, 2020 #Z-1096-2020
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.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 9
- Distribution
- Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
Vaginal Verification Panel Ref 8208 Lot 8208-11. Recalled by Microbiologics Inc. Units affected: 9.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-1096-2020.
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