biokitHSV-2 Rapid Test, REF: 300028001
FDA Recall Z-1021-2023 · Posted 2023-01-26
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Recalling FirmBiokit, S.A.
Recall StatusOpen, Classified
Product CodeLGC
Date Initiated2022-09-28
Product Quantity2,393
Reason for Recall
HSV-2 rapid test may report false positive results.
Firm Action
On 9/28/22, Werfen Field Action notices were emailed to customers who were asked to 1) Stop using and discard affected kits, 2) Complete and return the tracking form provided with the notice to [email protected], 3) Forward the notice to all affected facilities.
On 2/10/23, Werfen Field Action notices were emailed to additional customers informing them of an additional affected lot.
On 3/13/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot.
On 4/11/23, Werfen Field Action notices were emailed to an additional customer informing them of an additional affected lot.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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