Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay
Brand(s)
Last updated
Summary
Product
Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol 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 |
|---|---|---|
| Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay | More than 10 numbers, contact manufacturer. | OSR6196 |
| Beckman Coulter AU Immunochemistry System- HDL/LDL Cholesterol Assay | More than 10 numbers, contact manufacturer. | OSR6296 |
Issue
LDL cholesterol OSR6x96 does not meet the triglyceride interference claim per the BAOSR6x96 v10 IFU which states "no significant interference up to 1,500 mg/dl triglyceride" where the criteria for no significant interference is recovery within 10% of the initial value as outlined in the IFU.
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-81343
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