Roche Diagnostics Operations, Inc.: Medical Device Recall in 2024 - (Recall #: Z-3187-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190

Product Classification:

Class II

Date Initiated: August 15, 2024

Date Posted: October 2, 2024

Recall Number: Z-3187-2024

Event ID: 95221

Reason for Recall:

Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.

Status: Ongoing

Product Quantity: 6504 units

Code Information:

UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated