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Synermed®

INFRARED LABORATORY SYSTEMS LLC · Model IR750-X · UDI-DI 05060500090302

CIG Prescription

510(k) clearances

399

Adverse events

Recalls

Facilities

Description

Direct Bilirubin Reagent 2 X 250 mL

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.