Reported Feb 12, 2020 · Terminated
Vaginal Verification Panel Ref 8208 Lot 8208-11
Microbiologics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440
Is this the product you have?
- Vaginal Verification Panel Ref 8208 Lot 8208-11
- Lot codes and dates
- Lot 8208-11
- Amount recalled
- 9
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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