DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Reported: January 18, 2017 Initiated: December 19, 2016 #Z-1014-2017
Product Description
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858
Reason for Recall
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 1,282 units total (915 units in US)
- Distribution
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. Recalled by Beckman Coulter Inc.. Units affected: 1,282 units total (915 units in US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 18, 2017. Severity: Moderate. Recall number: Z-1014-2017.
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