Vaginal Verification Panel (Microbiologics) – contaminant detection (2020)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Vaginal Verification Panel Ref 8208 Lot 8208-11
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Lot 8208-11
Products Sold
Lot 8208-11
Microbiologics Inc is recalling Vaginal Verification Panel Ref 8208 Lot 8208-11 due to Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organis. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Letters will be sent via email to all consignees and end users regarding the correction. Users are to review the instructions, determine how the information affects their usage, and upon determination either use with new information or discard the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, KS, ME, NY, NC, OR, UT, VA
Page updated: Jan 10, 2026