Microbiologics recalls Vaginal Verification Panel Ref 8208 Lot 8208-11 due to Candida krusei contaminant in Pool 2. The recall explains the product's intended use for instrument verification and notes no impact on patient test results if Gardnerella vaginalis is properly detected.
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.
Microbiologics is recalling a specific lot of Vaginal Verification Panel Ref 8208 because Pool 2 contains Candida krusei. This contaminant is not expected to affect patient test results as long as Gardnerella vaginalis is properly detected during use for instrument verification.
The product contains Candida krusei in Pool 2, which is intended to be contained in Pool 6. However, the recall states this should not affect patient test results if Gardnerella vaginalis is properly detected during use for instrument verification.
Users of the Vaginal Verification Panel Ref 8208 Lot 8208-11 for instrument verification. Healthcare professionals using this product for lab validation are most at risk.
Check for the Vaginal Verification Panel Ref 8208 with Lot 8208-11. This specific lot number is associated with the contaminant issue.
Identify if your Vaginal Verification Panel has Lot 8208-11 to confirm it is affected.
No, the recall states this should not impact patient test results as long as Gardnerella vaginalis is properly detected during use for instrument verification.
Pool 2 contains Candida krusei, which is intended to be contained in Pool 6 of the kit.
The recall record does not specify a remedy.
We’ve drafted a message you can send Microbiologics to request your refund or repair — edit it as you like.
Subject: Recall Z-1096-2020 — Microbiologics Microbiologics Hello, I own a Microbiologics that is covered by recall Z-1096-2020 from Microbiologics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
