UniCel DxI 800 Access Immunoassay System
Brand(s)
Last updated
Summary
Product
UniCel DxI 800 Access Immunoassay System
Issue
Medical devices - Increased risk or new adverse events
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| ACCESS IMMUNOASSAY ANALYZERS - CLASS 3 | 123468 | 81910 |
| ACCESS SYSTEM - IMMUNOASSAY ANALYZERS CLASS 2 | 123468 | 81910 |
| ACCESS SYSTEM - THYROGLOBULIN ANTIBODY II | 124312 | A32898 |
| UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - INSTRUMENT REAGENTS | 123468 | 81910 |
| UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - SYSTEM REAGENTS | 123468 | 81910 |
| UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ANTIBODY II | 124312 | A32898 |
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - SYSTEM REAGENTS | 123468 | 81910 |
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - SYSTEM REAGENTS | 123468 | 81910 |
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM - THYROGLOBULIN ANTIBODY II] | 124312 | A32898 |
Issue
|
One shipment of the affected lot was frozen and thawed prior to shipment.
Recall date: 2021-10-07 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
|
BECKMAN COULTER, INC., 250 S. KRAEMER BLVD., BREA, CALIFORNIA |
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63536
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