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Class 2 Device Recall Creatinine |
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Date Initiated by Firm |
December 28, 2012 |
Date Posted |
March 15, 2013 |
Recall Status1 |
Terminated 3 on October 17, 2013 |
Recall Number |
Z-0958-2013 |
Recall Event ID |
64162 |
510(K)Number |
K924692 K934361
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Product Classification |
Alkaline picrate, colorimetry, creatinine - Product Code CGX
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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 CA 92821-6232
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For Additional Information Contact |
Clair K. ODonovan, Ph.D. 714-961-4483
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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.
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FDA Determined Cause 2 |
Labeling 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
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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.
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510(K) Database |
510(K)s with Product Code = CGX and Original Applicant = OLYMPUS CORP.
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