| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01526-1 |
| Product Name/Description |
ARCHITECT DHEA-S Reagents. An in vitro diagnostic medical device (IVD)
List Number: 8K27-20
Lot Numbers: 01316K000, 01217A000, 02217D000, 04117H000
List Number: 8K27-25
Lot Numbers: 01216K000, 01117A000, 02417D000, 00517F000
ARTG Number: 196075 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified that falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up to 60 days old. The specific cause of the elevated results is currently under investigation. Although falsely elevated results have only been observed with samples from infants up to 60 days old, the Expected Values representative data for children up to 10 years old provided in the ARCHITECT DHEA-S reagent insert should not be used as these reference ranges are being reviewed as part of the investigation.
All in-date lots of current reagent inventory are impacted. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abbot is advising users to immediately discontinue use of the ARCHITECT DHEA-S assay with samples from infants up to 60 days old and to immediately discontinue use of the ARCHITECT DHEA-S reagent insert Expected Values representative data for children up to 10 years old.
Users are advised to review this letter with the Medical Director and follow laboratory protocol regarding the need for reviewing previously reported patient results.
This action has been closed out on 18/02/2019 |
| Contact Information |
1800 816 696 - Abbott Customer Support |