| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01517-1 |
| Product Name/Description |
Architect Toxo IgM Assay
List Number: 6C20-25
Lot Numbers: 64245LI00 (Exp.: 12/04/2017), 66063LI00 (Exp.: 13/05/2017), 67003LI00 (Exp.: 12/05/2017), 68443LI00 (Exp.: 19/07/2017)
ARTG Number: 188821 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Diagnostics has identified an issue with the Architect Toxo IgM assay where an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for certain lot numbers. These sample types share the commonality of low total IgM titer. Internal studies with the Architect Toxo IgM assay have shown that pregnant women samples and serum and plasma blood donor samples are NOT impacted and meet assay specificity claims.
Assay sensitivity is NOT impacted. There is the potential for false reactive patient results that may be due to reduced specificity in low total IgM titer samples (eg. samples from immunocompromised patients or newborns or cord blood samples). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to review the letter with their Medical Director. Additional testing with a secondary method is recommended to confirm reactive results (= 0.60 Index or = 1.00 S/CO) for samples from immunocompromised patients or newborns or cord blood samples and other samples with expected low IgM concentrations. Abbott has identified a solution to address this issue with a planned product modification expected in Q1 2017.
This action has been closed out on the 08/11/2018. |
| Contact Information |
1800 816 696 - Abbott Customer Support |