CanadaBeckman Coulter AU Immunochemistry System – Bicarbonate (CO2) Assay (catalogue numbers OSR6237 and OSR6137; affected lots/serial numbers are listed as more than 10 numbers — contact the manufacturer for exact lot information). Health Canada reports customer complaints of false high bicarbonate results caused by elevated LDH in patient samples, and the current product instructions do not warn of LDH interference. Contact the manufacturer if you require 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: Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: OSR6237
Affected products: Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: OSR6137
The hazard
Customer complaints were received for multiple bicarbonate reagent lots associated with false high patient results for bicarbonate. The high results are due to elevated levels of LDH in the patient samples tested. The current bicarbonate product IFU's do not advise of LDH interference with this assay.
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