| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01067-1 |
| Product Name/Description |
Immunoassay Premium and Premium Plus controls when used with ACTH assays. An in vitro diagnostic medical device (IVD)
Immunoassay Premium Quality Controls
Catalogue Number: IA2633
Lot Numbers: 402366, 398703
Immunoassay Premium Plus Quality Controls
Catalogue Number: IA3109
Lot Numbers: 1573EC, 1619EC
Catalogue Number: IA3110
Lot Number: 1477EC
Catalogue Number: IA3111
Lot Numbers: 1478EC, 1578EC
Catalogue Number: IA3112
Lot Number: 377412, 398901
ARTG Number: 206767 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Randox has confirmed that ACTH in Immunoassay Premium Plus quality control and Immunoassay Premium quality control does not meet the quoted reconstituted stability claim in the product IFU. Randox now recommends that ACTH is to be assayed immediately after the 30-minute reconstitution procedure.
The quality control results which are not within range can lead to a delay in reporting ACTH results. ACTH is typically measured to aid in diagnosing the cause of abnormal cortisol. Abnormal cortisol levels are generally not associated with immediate life threatening disorders. Therefore a delay in ACTH reporting is unlikely to pose a serious risk to health. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Place a copy of the supplied notice in all impacted control kits, advising to assay ACTH immediately after the reconstitution procedure is complete.
2. Discuss the contents of the notice with the Medical Director.
This action has been closed out on the 24/12/2018. |
| Contact Information |
02 9615 4640 - Randox Technical Services |