ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467
FDA device recall Z-1951-2013 · posted 2013-08-10 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 718 units total (132 units in US)
- Distribution
- Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom
- Date initiated
- 2010-09-22
- Date posted
- 2013-08-10
- Date terminated
- 2013-08-10
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L (K965240) | Beckman Instruments, Inc. | 1997-03-10 |