FDAFDA · Food and drugs·Recall number Z-1096-2020
Vaginal Verification Panel Ref 8208 Lot 8208-11
Published February 12, 2020 · Recall initiated: January 3, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
- Lot
- Lot 8208-11
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.