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Multistix® Reagent Strips

Siemens Healthcare Diagnostics Inc. · Model 10339953 · UDI-DI 00630414551111

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1
510(k) clearances
563
Adverse events
29
Recalls
52
Facilities

Description

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, glucose, ketone (acetoacetic acid), pH, bilirubin and urobilinogen.

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

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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.