| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00519-1 |
| Product Name/Description |
Architect Sex Hormone Binding Globulin (SHBG) reagents. An in vitro diagnostic medical device (IVD)
List Number: 8K26-20
Lot Numbers: 01916E000, 00316F000, 01816G000, 00916I000, 07316I000 and 00916L000
List Number: 8K26-25
Lot Numbers: 01816E000, 00216F000, 01716G000, 00816I000 and 07216I000
ARTG Number: 196075 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified that Architect SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to results generated with serum. SHBG dimer destabilisation in EDTA could result in low SHBG measurements by immunoassay. In other words, there is a potential for falsely decreased ARCHITECT SHBG results to be generated when using the ARCHITECT SHBG assay with the Potassium EDTA specimen tube type.
Internal studies have determined the use of the Potassium EDTA specimen tube type may result in a decrease in SHBG concentration values of greater than 20% when compared with serum collected in serum tubes. The shift was observed across the full analytical range of the assay. As a result, an increase in Free Androgen Index / Free Testosterone Index calculations of up to 30% may also be observed when using Potassium EDTA specimen tubes. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbott Diagnostics is advising users to immediately discontinue the use of the Potassium EDTA specimen tube type with the ARCHITECT SHBG assay. Users are requested to review the recall notification with their Medical Director to ensure that they are aware of this issue and to determine if a review of previously generated results using the Potassium EDTA specimen tube type is required.
This action has been closed out on 7/09/2018. |
| Contact Information |
1800 816 696 - Abbott Customer Support |