Roche Diagnostics Operations, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2478-2019)

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 c513 Analyzer

Product Classification:

Class II

Date Initiated: July 18, 2019

Date Posted: September 11, 2019

Recall Number: Z-2478-2019

Event ID: 83525

Reason for Recall:

Quality issue with high pressure solenoid valves

Status: Terminated

Product Quantity: 2 units

Code Information:

Serial # :1731-08, 1722-03

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated