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U.S. Department of Health and Human Services

Class 2 Device Recall CKMBL Creatine KinaseMB

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 Class 2 Device Recall CKMBL Creatine KinaseMBsee related information
Date Initiated by FirmAugust 15, 2024
Date PostedSeptember 20, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3187-2024
Recall Event ID 95221
510(K)NumberK160570 
Product Classification Differential rate kinetic method, cpk or isoenzymes - Product Code JHS
ProductCreatine 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
Code Information UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024
FEI Number 1823260
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information ContactSAME
317-521-4343
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionRoche 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.
Quantity in Commerce6504 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JHS
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