Beckman Coulter Inc.: Medical Device Recall in 2014 - (Recall #: Z-1830-2014)

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 Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.

Product Classification:

Class II

Date Initiated: November 8, 2013

Date Posted: July 2, 2014

Recall Number: Z-1830-2014

Event ID: 67058

Reason for Recall:

Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.

Status: Terminated

Product Quantity: 768 units total (6 units in US)

Code Information:

Lot No. 3040200 3056140 3071360

Distribution Pattern:

Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated