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Recall Observatory FDA recall evidence

Device product

Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for components that come in contact with blood samples.

Z-1830-2014

November 08, 2013

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 67058
Status
Terminated
Classification
Class II
Quantity
768 units total (6 units in US)
Official record key
device-enforcement:Z-1830-2014

Official wording

Reason: 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.

Code information: Lot No. 3040200 3056140 3071360

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.