Z-3187-2024Class II

Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the...

Name: Z-3187-2024 Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the...
Creator: Roche Diagnostics Operations, Inc.
Published: 2024-08-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2024-08-15 / Open, Classified / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2024-08-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3187-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-15
Posted: 2024-09-20
Recalling firm: Roche Diagnostics GmbH
Product: 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 code: JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Roche issued Urgent Medical Device Corrections,TP-02225 and TP-02227 via UPS ground (08/15/2024). Roche engaged Sedgwick a third party recall company. Letter states reason for recall, health risk and action to take: Creatine Kinase kits, lot number 755471 expired on 06/30/2024. Ensure any inventory you have of this lot has been discarded per your local guidelines. " Follow your laboratory s standard operating procedures to determine specific clinical implications for your patients and whether retrospective review of patient results is required. " Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " If you received Recall Response Form (TP-02226) with this UMDC, complete all sections and fax it to 1-800-898-6169 or email it to [email protected] by September 1, 2024. If you did not receive the Recall Response Form with this UMDC, disregard this action. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information in this UMDC.
Quantity in commerce: 6504 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3187-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3187-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-20

Product code JHS

K160570Class IICreatine KinaseRoche Diagnostics Operations (Rdo) / cleared 2016-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)