Reported Feb 1, 2023 · Ongoing

biokitHSV-2 Rapid Test, REF: 300028001

Biokit, S.A.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biokit, S.A. · Avinguda De Can Montcau 7 · Llica D'Amunt, N/A · N/A

Is this the product you have?

  • biokitHSV-2 Rapid Test
  • REF300028001
Lot codes and dates
  • 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
Amount recalled
2,393

Where it was sold

Why it was recalled

HSV-2 rapid test may report false positive results.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:45 PM UTC

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