Z-0958-2013Class II

Creatinine, Part Numbers OSR6178, OSR6678

Name: Z-0958-2013 Creatinine, Part Numbers OSR6178, OSR6678
Creator: Beckman Coulter Inc.
Published: 2012-12-28
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-12-28 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman... on 2012-12-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0958-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-28
Posted: 2013-03-15
Terminated: 2013-10-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
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.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0958-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0958-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-27	2013-03-15

Product code CGX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)