RegWardenFDA facility compliance records
Facility

Ortho-Clinical Diagnostics, Inc.

1 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2024: 1 recalls20172018201920202021202220231202420252026
  • Recalls (1)

Devices registered here (2)

  • Reagent, Borrelia Serological Reagent
    Product code LSR (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3830
  • Assayed Quality Control Material For Clinical Microbiology Assays
    Product code QCH (opens in a new tab) · Class II · Microbiology · 21 CFR 866.3920

Recalls & enforcement

  • Class IIOngoing2024-04-09
    T3 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

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, Inc. (FEI 3021090658) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021090658-ortho-clinical-diagnostics-inc/

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