FDAClass IIFebruary 1, 2023

biokitHSV-2 Rapid Test recall

biokitHSV-2 Rapid Test, REF: 300028001

Why was biokitHSV-2 Rapid Test recalled?

HSV-2 rapid test may report false positive results.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
biokitHSV-2 Rapid Test, REF: 300028001
Recalling firm
Biokit, S.A.
Quantity
2,393
Distribution
US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Recall date
February 1, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls