PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 11, 2019 Initiated: July 18, 2019 #Z-2477-2019

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

Details

Units Affected
19 units
Distribution
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 19 units.
Why was this product recalled?
Quality issue with high pressure solenoid valves
Which agency issued this recall?
This recall was issued by the FDA Devices on September 11, 2019. Severity: Moderate. Recall number: Z-2477-2019.