CanadaBeckman Coulter UniCel DxI 600 Access Immunoassay System – Total T4 Assay (catalogue/model number 33805) with lot/serial numbers 538815, 539243, 538729, 538898, and 539107 is affected. Certain Access Total T4 calibrator lots exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications, which can cause false low patient results and poses a medium safety risk. Contact the manufacturer, Beckman Coulter, Inc., for additional information.
What's being recalled
Companies: Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, California, United States, 92821.
How to identify it
Affected products: UniCel DxI 600 Access Immunoassay System-Total T4 Assay; Lot or serial number: 538815; Model or catalogue number: 33805
Affected products: UniCel DxI 600 Access Immunoassay System-Total T4 Assay; Lot or serial number: 539243; Model or catalogue number: 33805
Affected products: UniCel DxI 600 Access Immunoassay System-Total T4 Assay; Lot or serial number: 538729; Model or catalogue number: 33805
Affected products: UniCel DxI 600 Access Immunoassay System-Total T4 Assay; Lot or serial number: 538898; Model or catalogue number: 33805
Affected products: UniCel DxI 600 Access Immunoassay System-Total T4 Assay; Lot or serial number: 539107; Model or catalogue number: 33805
The hazard
Access Total T4 calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. In the worst-case scenario, there is a medium safety risk associated with this issue due to the potential to cause false low patient results.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States