| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00023-1 |
| Product Name/Description |
Phadia ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, Amoxicilloyl
An in vitro medical device
Material Numbers: 14-4450-01 and 14-4451-01
Multiple Affected Lot Numbers
ARTG: 186054 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/01/2018 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been found with the stability of ImmunoCAP Allergen c5, Ampicilloyl and ImmunoCAP Allergen c6, Amoxicilloyl. An internal monitoring real time stability study determined that the stability specifications were not met. The products have a nominal 12 months shelf life stated on the label.
The reduced stability may result in erroneous test results for affected lot numbers.
No other ImmunoCAP tests are affected by this issue. No adverse events have been reported to date. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abacus is advising customers to discard any unused product. New product is expected to be available in Q3 2018.
A review of previous results reported below the assay Limit of Quantification is advised.
This action has been closed out on 21/06/2019 |
| Contact Information |
1800 222 287 - Abacus ALS |