| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00156-1 |
| Product Name/Description |
ACE Control. An in vitro diagnostic medical device (IVD)
Product Code: A6040
Lot Numbers: 042, 043 and 044
ARTG Number: 203619 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/02/2014 |
| Responsible Entity |
|
| Reason/Issue |
Upon review of the QA release testing, the range calculated at the time of kit release (done per standard operating procedures) supports the Control range assigned upon product release, i.e. 28-52 at 37°C. However, upon investigation of a complaint encompassing several lots of reagents, the assigned Control range has been reevaluated and it was determined that the range for these lots requires an adjustment to 23-43 at 37°C.
This recall action was carried out prior to approval of the recall strategy by the Therapeutic Goods Administration. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Immuno provided updated product information with the correct control ranges. |
| Contact Information |
02 9519 9300 - Immuno Pty Ltd |