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ROCHE COBAS 501 CHEMISTRY ANALYZER

Received Mar 28, 2025 · Event occurred Jan 27, 2025

Report MW5168347 · MDR key 21719892

Device

Generic name

Analyzer, Chemistry, Micro, For Clinical Use

Manufacturer

Roche Molecular Systems, Inc.

Model number

501

Patient

NA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

A1C RUN ON INSTRUMENT WERE ERRONEOUSLY ELEVATED. SPECIMENS REDRAWN AND TESTED RESULTED HISTORICAL VALUE NOT ELEVATED. MANUFACTURER NOTIFIED WHO DETERMINED A MISSING GASKET ON THE SAMPLE PROBE.