BIOKIT S.A.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
- Inspections (1)
Devices registered here (1)
- Antistreptolysin - Titer/Streptolysin O ReagentProduct code GTQ (opens in a new tab) · Class I · Microbiology · 21 CFR 866.3720
Recalls & enforcement
- Class IIOngoing2022-09-28HSV-2 rapid test may report false positive results.
FDA inspections (1)
- VAI2022-07-14Voluntary Action Indicated · Compliance: Devices; Project Evaluation: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “BIOKIT S.A. (FEI 3002806557) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806557-biokit-s-a/
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