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Pointe Scientific, Inc. Bilirubin, Total

HORIBA INSTRUMENTS INCORPORATED · Model HB979-2500 · UDI-DI 00811727014672

CIG Prescription

510(k) clearances

402

Adverse events

Recalls

Facilities

Description

Total Bilirubin Reagent, for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 1 x 2L, 1 x 500ml

Recalls

Date	Firm	Reason
2024-07-30	Siemens Healthcare Diagnostics, Inc.	During manufacturing, the last three tests from the 160 test flex of lot 23206BA (wells 8 or 10) were processed on the Dimension Vista platform. There was an issue with the filling
2023-08-05	Ortho-Clinical Diagnostics, INc.	Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate de
2020-07-13	Ortho-Clinical Diagnostics	Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
2020-07-13	Ortho-Clinical Diagnostics	Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
2020-02-13	Siemens Healthcare Diagnostics, Inc.	Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2020-02-13	Siemens Healthcare Diagnostics, Inc.	Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
2019-09-11	Roche Diagnostics Operations, Inc.	Due to low Quality Control recovery and invalid Calibration.
2019-08-15	Beckman Coulter Inc	It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quanti
2019-08-15	Beckman Coulter Inc	It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if present in high quanti
2018-12-17	Roche Diagnostics Corporation	New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D mod

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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.