FDA Device Intelligence
Home › HORIBA INSTRUMENTS INCORPORATED › Pointe Scientific, Inc.

Pointe Scientific, Inc.

HORIBA INSTRUMENTS INCORPORATED · Model C7548-1L · UDI-DI 00811727014474

JFY Prescription
1
510(k) clearances
567
Adverse events
29
Recalls
52
Facilities

Description

Creatinine Enzymatic, for the quantitative enzymatic determination of creatinine in serum and urine. For In Vitro Diagnostic Use Only. Size: 1 x 750 mL, 1 x 250 mL.

Recalls

DateFirmReason
2020-07-13Ortho-Clinical DiagnosticsEtrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
2020-05-04Siemens 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.
2020-05-04Siemens 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.
2020-05-04Siemens 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.
2020-05-04Siemens 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.
2019-12-18Siemens 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
2019-12-18Siemens 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
2019-12-18Siemens 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
2019-12-18Siemens 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
2019-08-15Beckman Coulter IncIt 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 keyRead 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.