biokitHSV-2 Rapid Test Recalled for Potential False Positive Results
The biokitHSV-2 Rapid Test has been recalled due to the potential for false positive results. The recall affects approximately 2,393 test kits distributed across NY, CA, IN, NC, and VA.
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 diagnostic device recall for accuracy defect. False positive results pose a risk of unnecessary medical intervention, but no illnesses or injuries have been reported. The hazard is theoretical rather than confirmed.
Plain-English summary
Biokit, S.A. is recalling the biokitHSV-2 Rapid Test (REF: 300028001) due to the potential for false positive results. The test may report positive results in patients who do not actually have HSV-2 infection.
Approximately 2,393 affected units were distributed nationwide across the states of New York, California, Indiana, North Carolina, and Virginia. The affected lot numbers and expiration dates are: B34243 (09/30/2022), B34309 (11/30/2022), B34463 (11/30/2022), B34465 (02/28/2023), B35052 (05/31/2023), B35188 (07/31/2023), and B35398 (10/31/2023).
Patients who received a positive result from a biokitHSV-2 Rapid Test should consult their healthcare provider. Confirmation testing may be warranted to ensure accurate diagnosis before beginning treatment.
The recalled product
- Product
- biokitHSV-2 Rapid Test, REF: 300028001
- Manufacturer
- Biokit, S.A.
- Category
- Medical Device — Diagnostic Test
- Affected units
- 2,393
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 (7)
- UDI-DI/Lots - Expiration Dates: 08426951056439/ B34243 - 2022-09-30
- B34309 - 2022-11-30
- B34463 - 2022-11-30
- B34465 - 2023-02-28
- B35052 - 2023-05-31
- B35188 - 2023-07-31
- B35398 - 2023-10-31
Distribution
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