FDA-Device2020-02-12Class II
Vaginal Verification Panel Ref 8208 Lot 8208-11
Microbiologics Inc
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.
Sold states
Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.
Affected count
9
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
Vaginal Verification Panel Ref 8208 Lot 8208-11
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1096-2020Don't want to check this manually?
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