UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.

Reason: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The events associated with the unusual light scatter pattern may be incorrectly removed from analysis which can result in an erroneous differential result.

Code information: all software versions

Distribution pattern: Worldwide distribution: US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan , Kuwait, Lebanon, Lithuania ,Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia , South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.