Z-1951-2013Class II

ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937...

Name: Z-1951-2013 ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937...
Creator: Beckman Coulter Inc.
Published: 2010-09-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-09-22 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE... on 2010-09-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1951-2013
Classification: Class II
Status: Terminated
Initiated: 2010-09-22
Posted: 2013-08-10
Terminated: 2013-08-10
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CEM Electrode, Ion Specific, Potassium
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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
Product codes and lots: Lot No. T006042

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1951-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1951-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-10

Product code CEM

K965240Class ISynchron Lx 20 Clinical Chemistry System, Synchron Lx Albumin Reagent, Synchron Lx Creatinine Picric Reagent, Synchron LBeckman Instruments, Inc. / cleared 1997-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)