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Recall Observatory FDA recall evidence

Device product

cobas¿ Liat¿ Analyzer

Z-2216-2016

May 09, 2016

Class II

Product summary

Firm
Roche Molecular Systems, Inc.
Event
Event 74094
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-2216-2016

Official wording

Reason: 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.

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

Distribution pattern: Distributed in NC and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.