Manufacturer
221 recalls in our database name Ortho-Clinical Diagnostics as the manufacturing or recalling firm.
Of the 221 recalls from Ortho-Clinical Diagnostics we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 10 (5%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products DAT Performance Verifier II because storage labeling errors may cause lower than expected VITROS BENZ results.
Ortho-Clinical Diagnostics is recalling 180 units of VITROS DAT Performance Verifier III because incorrect storage labeling may cause lower than expected test results.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.
Ortho-Clinical Diagnostics is recalling 16 enGen Track Systems with TCAutomation Software Version 4.2 due to a software anomaly that may delay result reporting.
Ortho-Clinical Diagnostics is recalling enGen Laboratory Automation Systems due to a software anomaly that may cause sample ID misassociation, potentially leading to misdiagnosis.
Ortho-Clinical Diagnostics is recalling specific lots of VITROS VANC Reagent because they may produce biased test results after being loaded on the analyzer.
Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP Reagent Packs because background signals are increasing, causing calibration failures.
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Lithium Slides due to intermittent imprecision in test results.
Ortho-Clinical Diagnostics is recalling VITROS UPRO Slides because they may produce variable urine protein results.
Ortho-Clinical Diagnostics is recalling VITROS FS Calibrator 1, Lot 91461, because it cannot calibrate dLDL reagents when used with specific Assay Data Disk versions.
Ortho-Clinical Diagnostics is recalling VITROS Na+ Slides because they may produce biased results if stored on the analyzer for 10 days after minimum warm-up.
Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to a positive bias of up to 20% and an incorrectly set reference interval.
Ortho-Clinical Diagnostics is recalling VITROS CRP Slides because the diluent contains endogenous CRP, which can cause falsely high test results if not subtracted.
Ortho-Clinical Diagnostics is recalling the enGen Laboratory Automation System because a software error may cause sample identification to be mismatched with assay results.
Ortho-Clinical Diagnostics is recalling VITROS HBsAg Controls because signal/cutoff results may increase during the 5-day reconstituted timeframe, potentially affecting performance monitoring.
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LAC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Ortho-Clinical Diagnostics is recalling VITROS URIC Slides because N-Acetylcysteine (NAC) can interfere with the assay results.
Ortho-Clinical Diagnostics is recalling VITROS GLU Slides because certain substances, including N-Acetylcysteine, may interfere with glucose measurements.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 31, Lot 3155, because an incorrect value on the Assay Data Disks prevents successful calibration of the HbA1c assay.
Ortho-Clinical Diagnostics is recalling VITROS TSH Reagent Packs because calibration curves frequently fall outside quality parameters, potentially delaying test results.
Ortho Clinical Diagnostics is recalling VITROS Estradiol Reagent Packs because the drug Fulvestrant causes falsely high test results in postmenopausal women.
Ortho-Clinical Diagnostics is recalling VITROS Total T4 Reagent Packs because test results may show a negative bias before the 8-week storage limit.
Ortho-Clinical Diagnostics is recalling VITROS Calcium Slides due to potential negatively biased results that may affect diagnosis.
Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Ortho-Clinical Diagnostics
in vitro diagnostics company for blood testing
Source: Wikidata (Q7104389), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.