Recall Z-2481-2015 ยท GIF Diluent, Blood Cell
Beckman Coulter Inc.
COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
| Date | Aug 28, 2015 (initiated Jul 22, 2015) |
| Status | Terminated |
| Reason | Beckman Coulter is recalling the LH 750 and LH780 Hematology Systems because the use of the diluent lots may eventually result in a compromised Hgb cuvette. |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall letter dated 7/22/15 was sent to the affected customers to inform them of the issue and actions to take. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with any questions are instructed to contact Beckman Coulter's Customer Support Center, http://www.beckmancoulter.com/customersupport/support, (800) 526-7694 in US and Canada. Customers outside of the US and Canada, are instructed to contact their local Beckman Coulter Representative. |
| Quantity | 710 units |
| Distribution | Distributed US (nationwide) including Puerto Rico and U.S. Virgin Islands and the countries of Bermuda, Canada, Guatemala, Hong Kong, Mexico, Panama, Taiwan, and Trinidad-Tobago. |
| FDA record | Open on fda.gov |