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

FDA device recall Z-3187-2024 · posted 2024-09-20 · Open, Classified

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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.

Action taken

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 roche2853@sedgwick.com 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JHS

Quantity affected

6504 units

Distribution

US Nationwide distribution.

Date initiated

2024-08-15

Date posted

2024-09-20

Location

Indianapolis, IN

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