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

Recall Z-1346-2013 — cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

U.S. FDA — Device Enforcement · United States · 2013-04-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1346-2013
Date of alert
2013-04-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Molecular Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05200881001
Reported risk: In rare instances, channel shifted results have been generated with cobas¿ 4800 assays run on v1.1.1 of the cobas¿ 4800 system. Raw data review indicates that, in these cases, all signals are shifted by one channel: channel 1 results report as channel 2, channel 2 results report as channel 3, channel 3 results report as channel 4, and channel 4 results report as channel 1. In the reported
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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