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Biokit, S.A. recalls
1 recall recorded since 2018, most recently on 28 September 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 September 2022
- Reason
- HSV-2 rapid test may report false positive results.
- Distribution
- US Nationwide distribution in the states of NY, CA, IN, NC, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1021-2023
- biokitHSV-2 Rapid Test, REF: 300028001
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.