QuidelOrtho Corporation
1 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (1)
Registered facilities (14)
- ORTHO-CLINICAL DIAGNOSTICS, INC. FEI 2250051 · NJ
- Ortho-Clinical Diagnostics, Inc. FEI 1000122536 · OH
- Ortho-Clinical Diagnostics, Inc. FEI 3033751096 · CA
- Ortho-Clinical Diagnostics, Inc. FEI 3021090658 · CA
- ORTHO-CLINICAL DIAGNOSTICS, INC. FEI 1000136573 · NY
- Ortho-Clinical Diagnostics European Support Center FEI 3000308930 · FR
- QUIDEL CORP. FEI 2024674 · CA
- Ortho Clinical Diagnostics, K.K. FEI 3012963943 · JP
- Ortho-Clinical Diagnostics Singapore Pte Ltd FEI 3002642396 · SG
- Ortho-Clinical Diagnostics FEI 3007111389 · GB
- ORTHO-CLINICAL DIAGNOSTICS, INC. FEI 1000305840 · NY
- Quidel Cardiovascular Inc. FEI 3013982035 · CA
- ORTHO-CLINICAL DIAGNOSTICS, INC. FEI 1000305841 · NY
- MICRO TYPING SYSTEMS, INC. FEI 1000132079 · FL
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…
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “QuidelOrtho Corporation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2024674-quidelortho-corporation/
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