| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00222-1 |
| Product Name/Description |
ImmunoCAP Allergen fx20, Food. An in vitro diagnostic medical device (IVD).
Lot Numbers:
AAS0D (exp 31 Mar 2012)
AAS0E (exp 31 Mar 2013)
AAS0F (exp 31 May 2014)
AAS0G (exp 30 Nov 2014)
AAS0H (exp 31 Jan 2015)
AASG1 (exp 31 Jul 2016)
AASG2 (exp 30 Jun 2016)
AASG3 (exp 30 Jun 2018)
ARTG Number:186054 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
21/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
ImmunoCAP Allergen fx20, Food contains a mix of f4 (Wheat), f5 (Rye), f6 (Barley), f9 (Rice). Due to a production non-conformity, certain lots of ImmunoCAP Allergen fx20, Food, may contain traces of oat (f7) allergen. This could cause false positive test results with regard to sensitisation to fx20 allergens for samples that are positive for oat allergen and negative for wheat, rye, barley, and rice allergens. However, this is an unlikely event because of the extensive cross-reactivity between the different cereal allergens and the low probability of monosensitisation to oat allergen in patients. Therefore, it is unlikely that presence of oat allergen in ImmunoCAP Allergen fx20 should result in incorrect test results for patient samples. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Abacus ALS is advising users of the possibility of false positives with the assay due to the presence of oat allergen. ImmunoCAP whole allergens f4, f5, f6 and f9 can be used as an alternative for testing of patient samples.
This action has been closed out on the 08/11/2018. |
| Contact Information |
1800 222 287 - Abacus ALS |