Roche Diagnostics Operations, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0387-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

Product Classification:

Class II

Date Initiated: September 27, 2016

Date Posted: November 16, 2016

Recall Number: Z-0387-2017

Event ID: 75357

Reason for Recall:

cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.

Status: Terminated

Product Quantity: 139

Code Information:

04777433001 Cobas c111 with ISE 04528778001 Cobas c111 without ISE cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated