Beckman Coulter Inc. recalls UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 8

Recalled September 14, 2016 · FDA recall Z-2732-2016 · Beckman Coulter

Hazard

There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. · FDA Class II

Units

5,282 units total (2,877 units in US)

Sold at

Affected geographies: Andorra, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Egypt, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.

Description

There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.

Product

UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800 Coulter Cellular Analysis System). Catalog No. B23858 (Unicel DxH600 Coulter Cellular Analysis System).

Manufacturer(s)

Beckman Coulter Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →