Recall Z-1021-2023— Biokit, S.A.

Name: FDA recall Z-1021-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-28

Class II · Ongoing

Class II FDA medical device recall by Biokit, S.A., initiated 2022-09-28. It names one FDA 510(k) clearance: K983886. Product: biokitHSV-2 Rapid Test, REF: 300028001. Reason: HSV-2 rapid test may report false positive results..

Recalling firm: Biokit, S.A.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-28
Firm location: Llica D'Amunt, N/A, Spain

510(k) clearances named in this recall

1 on FDA's record

K983886 — POCKIT HSV 2 RAPID TESTDiagnology , Ltd.·cleared 1999-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

biokitHSV-2 Rapid Test, REF: 300028001

Reason for recall

HSV-2 rapid test may report false positive results.

Data sourced from openFDA. This site is unofficial and independent of the FDA.