Access System - Free T3 Assays
Brand(s)
Dernière mise à jour
Summary
Produit
Access System - Free T3 Assays
Problème
Medical devices - Performance issue
Ce qu’il faut faire
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 |
Problème
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: 2023-03-29
Type d’avis ou de rappel
Health product recall
Catégorie
Health product - Medical device - Chemistry
Entreprises
Beckman Coulter, Inc.
250 S. Kraemer Blvd., Brea, California, United States, 92821
Published by
Health Canada
Audience
Healthcare
Classe de rappel
Type II
Identification number
RA-73409