Reported Mar 27, 2013 · Terminated
Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reagent for the quantitative determination of…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Creatinine, Part Numbers OSR6178
- OSR6678 Product UsageSystem reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers
- Lot codes and dates
- All
- Amount recalled
- 57,962 units (50,452 units in the US)
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Beckman Coulter Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.