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Beckman coulter au immunochemistry system - bicarbonate (co2) assay
Official notice
17 Oct 2025
Last checked
17 Oct 2025
An official Health Canada notice concerns Beckman coulter au immunochemistry system - bicarbonate (co2) assay. 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. Published 2025-10-17.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78310
Official notice
2025-10-17
The hazard
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.
How to check if you're affected
How to check if you're affected
Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.
Recall Numbers
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Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected vehicles were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: Beckman Coulter, Beckman Coulter Au Immunochemistry System - Bicarbonate Assay.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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