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U.S. Department of Health and Human Services

Class 2 Device Recall Creatinine

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 Class 2 Recall
Creatinine
see related information
Date Posted March 15, 2013
Recall Status1 Terminated on October 17, 2013
Recall Number Z-0958-2013
Recall Event ID 64162
Premarket Notification
510(K) Numbers
K924692  K934361 
Product Classification Alkaline Picrate, Colorimetry, Creatinine - Product Code CGX
Product Creatinine, 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, California 92821-6232
For Additional Information Contact Clair 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
DESIGN: Device Design
Action Beckman 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 Commerce 57,962 units (50,452 units in the US)
Distribution Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CGX and Original Applicant = OLYMPUS CORP.
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