Access System - Free T3 Assays
Brand(s)
Last updated
Summary
Product
Access System - Free T3 Assays
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 catalog number |
|---|---|---|
| Unicel DxI 600 Access Immunoassay System - Free T3 Assay | 233968 | A13422 |
| Unicel DxI 800 Access Immunoassay System - Free T3 Assay | 233968 | A13422 |
| Access System - Free T3 Assay | 233968 | A13422 |
Issue
Beckman Coulter has determined that Access Free T3 reagent lot 233968 included an insufficient concentration of blocking reagent. Patient samples tested with Access Free T3 reagent lot 233968 may demonstrate repeatable falsely elevated results, which are caused by insufficiently blocked interferents.
Recall start date: March 20, 2023
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
Identification number
RA-73409
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