CLASS II ONGOING Device recall · Reported 1 Feb 2023 · FDA Enforcement Report
biokitHSV-2 Rapid Test recalled
Biokit is recalling biokitHSV-2 Rapid Test, distributed nationwide in the US. The recall was initiated on 28 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1021-2023
- FDA event ID
- 91384
- Recalling firm
- Biokit, Llica D'Amunt, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Sep 2022
- FDA classified
- 26 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Sep 2022 | Recall initiated by company | |
| 26 Jan 2023 | Classified by FDA | +120 days |
| 1 Feb 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
HSV-2 rapid test may report false positive results.
Product as listed by the FDA
biokitHSV-2 Rapid Test, REF: 300028001
Where it was distributed
US Nationwide distribution in the states of NY, CA, IN, NC, VA.
Questions about this recall
Is biokitHSV-2 Rapid Test recalled?
Yes. Biokit recalled biokitHSV-2 Rapid Test on 28 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-1021-2023.
Why was it recalled?
HSV-2 rapid test may report false positive results.
Which lots 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
Where was it sold?
US Nationwide distribution in the states of NY, CA, IN, NC, VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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