Beckman Coulter Inc.: Medical Device Recall in 2014 - (Recall #: Z-2651-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Coulter DxH Diluent, Catalog No. 628017 Blood cell analysis comprises diluting a whole-blood sample with a solution that functions as a diluent. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types and the measurement of hemoglobin.

Product Classification:

Class II

Date Initiated: August 25, 2014

Date Posted: September 24, 2014

Recall Number: Z-2651-2014

Event ID: 69112

Reason for Recall:

Beckman Coulter is recalling Coulter DxH Diluent because it may be associated with elevated platelet (PLT) background counts between 3-7 x 10(3) cells/uL. This will result in failed Daily Checks on the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems.

Status: Terminated

Product Quantity: 46,050 units total (40,078 units in US)

Code Information:

Lot No. 3510470, 3510480, 3510490, 3510500, 3510510, 3510520, 3510530, 3510540, 3510550, 3510570, 3510580, 3510590, 3510600, 3510610, 3510620, 3510630, 3510690.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Chile, Mexico, Panama, and Thailand. .

Voluntary or Mandated:

Voluntary: Firm initiated