| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00789-1 |
| Product Name/Description |
Allergenic Extract – Pecan Nut (Food)
Lot numbers: 0003963971 (5 mL) / 0003963972 (10 mL)
Expiry date: February 4, 2024
Product is exempt from the ARTG |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
11/09/2023 |
| Responsible Entity |
|
| Reason/Issue |
ALK-Abelló, Inc. has been made aware of multiple adverse events from the market resulting from diagnostic skin testing using the Pecan Nut (Food)
extract product lot 0003963971 in 5mL packaging configuration at 1:10 w/v.
According to these reports, individuals who were test-negative using the product lot subsequently experienced allergic reactions to Pecan Nut (Food). Consequently, Pecan Nut (Food)extract product lots 0003963971 (5 mL) / 0003963972 (10 mL) will be recalled from the market. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to examine their stock immediately to determine if they have any of the product lots referenced. If so, discontinue testing with the lot(s) immediately. ASML will issue a credit to their account for all returned vials upon receipt of the customer acknowledgement form.
ALK are also notifying all customers that the allergenic extract product insert For Diagnostic Use Only (112S) has been updated to include new safety information for risk of anaphylaxis following false negative food allergy skin test results in the "Warnings" section. The added statement instructs healthcare providers to consider conducting additional testing for confirming negative skin testing results.
This action has been closed out on 29/11/2023 |
| Contact Information |
(02) 9882 3666 - AMSL |