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.
What this means for you
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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