Privapath Diagnostics Ltd
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- Urine Collection Kit (Excludes Hiv Testing)Product code OIE (opens in a new tab) · Class I · Pathology · 21 CFR 864.3250
Recalls & enforcement
- Class IIOngoing2022-03-16Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identificati…
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. “Privapath Diagnostics Ltd (FEI 3015209536) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015209536-privapath-diagnostics-ltd/
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