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T BIL

RANDOX LABORATORIES LIMITED · Model BR9766 · UDI-DI 05055273208337

JFM Prescription
1
510(k) clearances
31
Adverse events
9
Recalls
6
Facilities

Description

The device is intended for the quantitative in vitro determination of total bilirubin in serum or plasma.

Recalls

DateFirmReason
2023-10-11Randox Laboratories Ltd.Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2023-07-10Siemens Healthcare Diagnostics, Inc.Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atell
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-02-13Siemens Healthcare Diagnostics, Inc.Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.