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
Product summary
- 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
Quality issue with high pressure solenoid valves