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Recall Observatory FDA recall evidence

Device product

cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR SYSTEMS analyzers.

Z-0102-2017

July 15, 2016

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 75186
Status
Terminated
Classification
Class II
Quantity
9014 in total
Official record key
device-enforcement:Z-0102-2017

Official wording

Reason: 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 been revised to clarify the cleaning process.

Code information: Not applicable

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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 been revised to clarify the cleaning process.