Home › HORIBA INSTRUMENTS INCORPORATED › Pointe Creatinine, Enzymatic Reagent

Pointe Creatinine, Enzymatic Reagent

HORIBA INSTRUMENTS INCORPORATED · Model 16-C7548-240 · UDI-DI 00811727016072

JFY Prescription

510(k) clearances

567

Adverse events

Recalls

Facilities

Description

Pointe Creatinine, Enzymatic Reagent packaged for use on the Mindray BA800. 3 x 60ml R1, 3 x 20ml R2. For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only.

Recalls

Date	Firm	Reason
2020-07-13	Ortho-Clinical Diagnostics	Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2020-05-04	Siemens Healthcare Diagnostics, Inc.	The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
2019-12-18	Siemens Healthcare Diagnostics, Inc.	There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the
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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.