—#115469

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.

FDA product code: CGX — Alkaline Picrate, Colorimetry, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K924692, K934361
Affected lot / code info: All

Why it was recalled

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.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.

Timeline

Recall initiated: 2012-12-28
Posted by FDA: 2013-03-15
Terminated: 2013-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115469. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.