FDA Recalls V8 Immunodisplacement Kit Due to Microbial Contamination
Helena Laboratories is recalling the V8 Immunodisplacement Kit (51 units) due to microbial contamination that interferes with test interpretation. The FDA Class II recall affects kits distributed in the U.S. and internationally.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with microbial contamination potentially affecting test result accuracy. No illnesses or injuries reported. Meets High severity criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Helena Laboratories, Corp. is recalling the V8 Immunodisplacement Kit REF 1803 due to microbial growth that can interfere with test result interpretation. The recall involves 51 kits distributed in the United States and internationally.
The affected kits were distributed to facilities in Florida, Missouri, Ohio, and Texas within the U.S., and to Canada, Uruguay, and Vietnam internationally. Affected lot numbers are 3-21-1803 and 1-22-1803.
This Class II medical device recall was issued by the FDA because microbial contamination can compromise the reliability of test results produced by the kit. The contamination causes interference with the interpretation of diagnostic findings.
The recalled product
- Product
- V8 Immunodisplacement Kit REF 1803
- Manufacturer
- Helena Laboratories, Corp.
- Affected units
- 51
Distribution
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