FDAFDA · Food and drugs·Recall number Z-1014-2017
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Published January 18, 2017 · Recall initiated: December 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System may not flag or detect blasts in some blood samples. This is due to limitations in the available technology as well as sample limitations.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, France, Germany, Gibraltar, Ecuador Hong Kong, India, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, New Zealand, Oman, Panama, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.
- Lot
- Serial Numbers: All
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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