Ortho Clinical Diagnostics, K.K.
1 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (1)
Devices registered here (1)
- Micro PipetteProduct code JRC (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.2050
Recalls & enforcement
- Class IIOngoing2024-04-09T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results or a delay in testing that may impact patient management, clinical assessment, and the results of ot…
Related
- All facilities operated by QuidelOrtho Corporation
- ORTHO-CLINICAL DIAGNOSTICS, INC. (NJ)
- Ortho-Clinical Diagnostics, Inc. (OH)
- Ortho-Clinical Diagnostics, Inc. (CA)
- Ortho-Clinical Diagnostics, Inc. (CA)
- ORTHO-CLINICAL DIAGNOSTICS, INC. (NY)
- Ortho-Clinical Diagnostics European Support Center (FR)
- QUIDEL CORP. (CA)
- Ortho-Clinical Diagnostics Singapore Pte Ltd (SG)
- Ortho-Clinical Diagnostics (GB)
- ORTHO-CLINICAL DIAGNOSTICS, INC. (NY)
- Quidel Cardiovascular Inc. (CA)
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. “Ortho Clinical Diagnostics, K.K. (FEI 3012963943) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012963943-ortho-clinical-diagnostics-k-k/
Alerts for Ortho Clinical Diagnostics, K.K.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.