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Recall Observatory FDA recall evidence

Device product

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Z-2476-2019

July 18, 2019

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 83525
Status
Terminated
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-2476-2019

Official wording

Reason: Quality issue with high pressure solenoid valves may cause inaccurate results.

Code information: Serial # : 31A1-01

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 may cause inaccurate results.