UniCel DxI 600 Access Immunoassay System-Total T4 Assay
Brand(s)
Last updated
Summary
Product
UniCel DxI 600 Access Immunoassay System-Total T4 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 |
|---|---|---|
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 538815 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 539243 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 538729 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 538898 | 33805 |
| UniCel DxI 600 Access Immunoassay System-Total T4 Assay | 539107 | 33805 |
Issue
Access Total T4 calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. In the worst-case scenario, there is a medium safety risk associated with this issue due to the potential to cause false low patient results.
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-81777
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