Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantita...

FDA Recall #Z-0958-2013 — Class II — December 28, 2012

Recall #Z-0958-2013 Date: December 28, 2012 Classification: Class II Status: Terminated

Product Description

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.

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.

Recalling Firm

Beckman Coulter Inc. — Brea, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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.

Code Information

All

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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