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Recall Observatory FDA recall evidence

Device product

Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001

Z-2477-2019

July 18, 2019

Class II

Product summary

Firm
Roche Diagnostics Operations, Inc.
Event
Event 83525
Status
Terminated
Classification
Class II
Quantity
19 units
Official record key
device-enforcement:Z-2477-2019

Official wording

Reason: Quality issue with high pressure solenoid valves

Code information: cobas c 701 module Serial # : 19P2-01, 1390-03, 1139-04, 1139-05, 1139-06. cobas c 702 module serial # : 1126-03, 1237-10, 14C2-04 cobas¿ 8000 ISE module serial # : 1943-01, 1943-02, 1943-03, 1943-04, 1943-05, 1943-06, 1943-07, 1943-08, 1943-09, 1943-10, 15B3-05.

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