UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
Reported: May 31, 2017 Initiated: April 24, 2017 #Z-2158-2017
Product Description
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 1408 units total (998 units in US)
- Distribution
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858.. Recalled by Beckman Coulter Inc.. Units affected: 1408 units total (998 units in US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2017. Severity: Moderate. Recall number: Z-2158-2017.
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