Recall MonitorHealth Products
Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay | More than 10 numbers, contact manufacturer. | OSR6237 |
| Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay | More than 10 numbers, contact manufacturer. | OSR6137 |
Issue
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.