FDA recall record · openFDA

ORTHO-CLINICAL DIAGNOSTICS

5 FDA recalls on record (2023–2024) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, 2

The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue 2

Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferr 1

Recalls

VITROS Performance Verifier I Class II 2024-02-27 VITROS Performance Verifier II Class II 2024-02-27 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Class II 2023-06-05 VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 20- Class II 2023-05-08 VITROS Immunodiagnostic Products Troponin I ES Calibrators Class II 2023-06-05

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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