UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Reported: July 2, 2014 Initiated: November 8, 2013 #Z-1829-2014
Product Description
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Reason for Recall
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 164 units total (106 units in US)
- Distribution
- Worldwide Distribution -- US, Canada, Australia, China, Belgium, Brunei Darssalam, Colombia, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Macao, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Panama, Portugal, Puerto Rico, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.. Recalled by Beckman Coulter Inc.. Units affected: 164 units total (106 units in US).
Why was this product recalled? ▼
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1829-2014.
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