Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0499-2018 — Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a ful

U.S. FDA — Device Enforcement · United States · 2017-07-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0499-2018
Date of alert
2017-07-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
11568248001
Reported risk: A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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