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U.S. Department of Health and Human Services

Class 2 Device Recall biokitHSV2 Rapid Test

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  Class 2 Device Recall biokitHSV2 Rapid Test see related information
Date Initiated by Firm September 28, 2022
Date Posted January 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-1021-2023
Recall Event ID 91384
510(K)Number K983886  
Product Classification Enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific - Product Code LGC
Product biokitHSV-2 Rapid Test, REF: 300028001
Code Information 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
Recalling Firm/
Manufacturer		 Biokit, S.A.
Avinguda De Can Montcau 7
(Barcelona)
Llica D'Amunt Spain
Manufacturer Reason
for Recall		 HSV-2 rapid test may report false positive results.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 oem-complaints@werfen.com, 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.
Quantity in Commerce 2,393
Distribution US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LGC and Original Applicant = DIAGNOLOGY LTD.
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