| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00912-1 |
| Product Name/Description |
ImmunoCAP Allergen f205, Herring. An in vitro diagnostic medical device (IVD)
Product Number: 14-4837-01
Lot Number: 999G5
ARTG Number: 186054 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
2/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Abacus ALS is advising that ImmunoCAP Allergen f205, Herring, lot 999G5 contains the wrong allergen. This could cause erroneous test results, which may cause a delay in a proper diagnosis, however, the probability of a serious adverse health consequence or serious deterioration in state of health due to a delayed diagnosis is estimated to be negligible. |
| Recall Action |
Recall |
| Recall Action Instructions |
Actions to be taken by the customer/user:
1. Stop using the affected lots;
2. Discard any unused product;
3. Retest any samples that have been tested using the affected product; and
4. Fill in the Medical Device Recall return response form supplied with the customer letter and return to Abacus ALS.
This action has been closed out on the 16/10/2018. |
| Contact Information |
1800 222 287 - Abacus ALS |