Recalls / —
—#119820
Product
ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.
- FDA product code
- CEM — Electrode, Ion Specific, Potassium
- Device class
- Class 2
- Medical specialty
- Clinical Chemistry
- 510(k) numbers
- K965240
- Affected lot / code info
- Lot No. T006042
Why it was recalled
Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because it has a potassium (K) response near the instrument calibration flag limits and may exceed the limits on some instruments.
Root cause (FDA determination)
Process control
Action the firm took
Beckman Coulter Inc sent an Urgent Product Corrective Action (PCA) letter dated September 22, 2010 to all affected customers. Customers were notified of the the problems identified and the actions to be completed. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and in Canada.
Recalling firm
- Firm
- Beckman Coulter Inc.
- Address
- 250 S Kraemer Blvd, Brea, California 92821-6232
Distribution
- Distribution pattern
- Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom
Timeline
- Recall initiated
- 2010-09-22
- Posted by FDA
- 2013-08-10
- Terminated
- 2013-08-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #119820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.