Z-2477-2019 Class II Terminated

Recalled by Roche Diagnostics Operations, Inc. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
September 11, 2019
Initiation Date
July 18, 2019
Termination Date
June 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

Product Description

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

Reason for Recall

Quality issue with high pressure solenoid valves

Distribution Pattern

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

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.