Creatinine, Part Numbers OSR6178, OSR6678 recallZ-0958-2013 · Beckman Coulter Inc. · initiated Dec 28, 2012
Class II Terminated All recalls posted in March 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-0958-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 28, 2012
- Posted by the FDA
- Mar 15, 2013
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 57,962 units (50,452 units in the US)
- Product code
- CGX
- FDA submissions
- K924692, K934361
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of: Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
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.
Code information (models, lots, serial numbers)
All
Other devices under the same FDA submission
1 device cleared under K924692, K934361 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AU OSR6178Beckman Coulter, Inc. · Alkaline Picrate, Colorimetry, Creatinine1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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