Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2476-2019)

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 e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Product Classification:

Class II

Date Initiated: July 18, 2019

Date Posted: September 11, 2019

Recall Number: Z-2476-2019

Event ID: 83525

Reason for Recall:

Quality issue with high pressure solenoid valves may cause inaccurate results.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Serial # : 31A1-01

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated