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Multistix® 10 SG Reagent Strips

Siemens Healthcare Diagnostics Inc. · Model 10336425 · UDI-DI 00630414548968

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1
510(k) clearances
547
Adverse events
7
Recalls
53
Facilities

Description

Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity, bilirubin and urobilinogen.

Recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2024-04-04Macherey Nagel Gmbh & Co. KgThe reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Sc
2016-07-15Roche Diagnostics Operations, Inc.Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has be
2014-12-08Beckman Coulter Inc.Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
2014-09-19Siemens Healthcare Diagnostics, IncThe external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
2014-09-19Siemens Healthcare Diagnostics, IncThe external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.
2014-09-19Siemens Healthcare Diagnostics, IncThe external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User.

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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.