Lower riskMedical device recall · FDA · Published January 3, 2020
Microbiologics Vaginal Verification Panel 8208 Lot 8208-11 Recall: Contaminant Risk
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.
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Contact the company
📍Recalling firmMicrobiologics Inc200 Cooper Ave N · Saint Cloud, MN 56303-4440
“Microbiologics Vaginal Verification Panel 8208 Lot 8208-11 Recall: Contaminant Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66169-microbiologics-vaginal-verification-panel-8208-lot-8208-11-recall-contaminant. Based on FDA recall #Z-1096-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2020%22&limit=1).
The FDA announced on Jan. 3, 2020, that Microbiologics Inc voluntarily recalled the Vaginal Verification Panel Ref 8208 Lot 8208-11 due to contamination with Candida krusei in Pool 2. The agency stated the recall was initiated by the firm.
How to tell if you have it
Brand: Microbiologics
Product: Vaginal Verification Panel Ref 8208 Lot 8208-11
Quantity: 9 units
The hazard
The product is a 6 pool kit containing the contaminant Candida krusei in Pool 2, which is an organism intended to be contained in Pool 6. The FDA stated 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.
Context
GovInfoNow's records show Microbiologics Inc has 35 other recalls on record since June 6, 2017. Other recent recalls of similar products include Medline Convenience Kits Recall (Aug. 11, 2026) and Hologic ThinPrep CytoLyt Solution Recall (Dec. 12, 2025). On June 27, 2025, Microbiologics issued a recall for LYFO-DISK kits due to the risk of failed microorganism recovery.
How to tell if you have this one
Check for the Vaginal Verification Panel Ref 8208 with Lot 8208-11. This specific lot number is associated with the contaminant issue.
Brand
Microbiologics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Identify if your Vaginal Verification Panel has Lot 8208-11 to confirm it is affected.
Where it went and when
Where it was distributed
Distributed in 8 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Kansas, Maine, New York, North Carolina, Oregon, Utah, Virginia.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1096-2020 (January 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1096-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.