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U.S. Department of Health and Human Services

Class 2 Device Recall Creatinine

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 Class 2 Device Recall Creatininesee related information
Date Initiated by FirmDecember 28, 2012
Date PostedMarch 15, 2013
Recall Status1 Terminated 3 on October 17, 2013
Recall NumberZ-0958-2013
Recall Event ID 64162
510(K)NumberK924692 K934361 
Product Classification Alkaline picrate, colorimetry, creatinine - Product Code CGX
ProductCreatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
Code Information All
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactClair K. ODonovan, Ph.D.
714-961-4483
Manufacturer Reason
for Recall		Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.
FDA Determined
Cause 2		Labeling design
ActionBeckman Coulter sent an Urgent Product Correction letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed the customers that Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance. Customers are instructed to complete and return the enclosed response form. Customers with questions about the notification letter are instructed to contact the call center (hotline) at (800) 854-3633 in the US and Canada.
Quantity in Commerce57,962 units (50,452 units in the US)
DistributionWorldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = CGX
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