Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2477-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 18, 2019

Date Posted: September 11, 2019

Recall Number: Z-2477-2019

Event ID: 83525

Reason for Recall:

Quality issue with high pressure solenoid valves

Status: Terminated

Product Quantity: 19 units

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

Voluntary or Mandated:

Voluntary: Firm initiated