Microbiologics Recalls Vaginal Verification Panel Due to Contamination
Microbiologics Inc is recalling 9 units of the Vaginal Verification Panel Lot 8208-11 because Pool 2 contains the wrong organism, Candida krusei.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source text explicitly states that the contamination should have no impact on patient test results under specific conditions, characterizing the issue as a low-risk contamination or labeling error rather than a direct health hazard.
Plain-English summary
Microbiologics Inc is recalling 9 units of the Vaginal Verification Panel (Ref 8208, Lot 8208-11). The recall is due to the presence of the organism Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit, not Pool 2.
The product was distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. The source text notes that this contamination 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.
The recalled product
- Product
- Vaginal Verification Panel Ref 8208 Lot 8208-11
- Manufacturer
- Microbiologics Inc
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 8208-11
Distribution
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