Recall Z-1831-2014 ยท JCB Detergent
Beckman Coulter Inc.
Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems for components that come in contact with blood samples.
| Date | Jun 20, 2014 (initiated Nov 8, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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, cus |
| Quantity | 12,924 units total (9,733 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, Philipp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.