| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01071-1 |
| Product Name/Description |
ImmunoCAP Rare Allergen k220, Allergen component rHev b 6.02 Latex. An in vitro diagnostic medical device (IVD)
Product code: PU14532901
Lot number: C22GM
Expiry date: 31/01/2024
ARTG 229585
(Abacus dx Pty Ltd - Clinical chemistry autoimmune IVDs)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/12/2023 |
| Responsible Entity |
|
| Reason/Issue |
An investigation has shown that ImmunoCAP Rare Allergen k220, Allergen component rHev b 6.02 Latex, has been contaminated with Fel d 7 (cat allergen component) during manufacturing.
This can give false positive or falsely elevated results for specific IgE and specific IgG/IgG4, respectively.
Falsely positive or falsely elevated test results for an occupational allergen such as latex may lead to unnecessary avoidance resulting in patient’s discomfort and inconvenience. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to immediately inspect and destroy their affected stock. Customers are to check if they have received any positive results that may need retesting.
Abacus dx will provide customers with replacement stock. |
| Contact Information |
1800 222 287 - Abacus dx Pty Ltd |