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Recall Observatory FDA recall evidence

Device product

cobas c513 Analyzer

Z-2478-2019

July 18, 2019

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 83525
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-2478-2019

Official wording

Reason: Quality issue with high pressure solenoid valves

Code information: Serial # :1731-08, 1722-03

Distribution pattern: State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Quality issue with high pressure solenoid valves