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.
FDA Recall Z-2481-2015 · Posted 2015-08-28
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGIF
Date Initiated2015-07-22
Date Terminated2015-12-18
Product Quantity710 units
Reason for Recall
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.