Beckman Coulter Inc.: Medical Device Recall in 2013 - (Recall #: Z-1951-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 22, 2010

Date Posted: August 21, 2013

Recall Number: Z-1951-2013

Event ID: 65655

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.

Status: Terminated

Product Quantity: 718 units total (132 units in US)

Code Information:

Lot No. T006042

Distribution Pattern:

Worldwide Distribution - USA Nationwide and the countries of Belgium, France, Germany, Netherlands, Poland, Spain, Sweden, Switzerland, and United Kingdom

Voluntary or Mandated:

Voluntary: Firm initiated