Home / Recalls / Roche Molecular Systems, Inc. / Z-2216-2016

Z-2216-2016 Class II Terminated

Recalled by Roche Molecular Systems, Inc. — Branchburg, NJ

Recall Details

Product Type: Devices
Report Date: July 27, 2016
Initiation Date: May 9, 2016
Termination Date: March 24, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2

Product Description

cobas¿ Liat¿ Analyzer

Reason for Recall

Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.

Distribution Pattern

Distributed in NC and WA.

Code Information

US-IVD: M1-E-00383 & M1-E-00434

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