—#124629

Product

UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for in vitro diagnostic use in screening patient populations found in clinical laboratories.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081930, K120771
Affected lot / code info: All serial numbers

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Product Correction letter, dated 11/08/2013, was sent to all the customers who purchased the UniCel DxH 800 and UniCel DxH 600 Coulter Cellular Analysis Systems. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions are instructed to contact Beckman Coulter's Customer Support Center via website, http://www.beckmancoulter.com/customersupport/support, via phone at (800) 526-7694 in US and Canada. For outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative. Beckman Coulter sent an update on 2/14/14, to inform customers that the recall was expanded to include specific lots of DxH Cleaner.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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.

Timeline

Recall initiated: 2013-11-08
Posted by FDA: 2014-06-20
Terminated: 2014-12-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124629. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.