Beckman Coulter AU Immunochemistry System - Bicarbonate (CO2) Assay
Brand(s)
Last updated
Summary
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
Affected 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.
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-78310
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