Home / Recalls / Beckman Coulter Inc. / Z-2157-2017

Z-2157-2017 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

Recall Details

Product Type
Devices
Report Date
May 31, 2017
Initiation Date
April 24, 2017
Termination Date
May 22, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4880 units total (2119 units in US)

Product Description

UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304, B63322.

Reason for Recall

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.

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.

Code Information

all software versions

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