FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-0958-2013
- Recalling firm
- Beckman Coulter 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.
- Status
- Terminated
- Initiated
- 2012-12-28
- Posted
- 2013-03-15
- Terminated
- 2013-10-17
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- All
- 510(k) numbers
- ["K924692","K934361"]
- PMA numbers
- not on file
- Product code
- CGX
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28