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 |