| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00125-1 |
| Product Name/Description |
Foetal Haemoglobin Monoclonal Antibody (HBF-1), FITC. An in vitro diagnostic medical device (IVD)
Catalogue Number: MHFH01
Lot Number: 1626670D
Expiry Date: 30/04/2018
ARTG Number: 212744 - (Life Technologies Australia - Haemoglobin IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
Life Technologies has become aware of a performance issue where the specific lots of Foetal Haemoglobin Monoclonal antibody are displaying high or unusually bright background which could potentially lead to erroneous(false positive) results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Life Technologies is advising users to discard any remaining product of the affected lot.
A product hold has been placed on future stock, and a credit will be provided for all affected stock.
A review of previously generated test results should be performed at the discretion of the laboratory Director.
This action has been closed out on 07/11/2018 |
| Contact Information |
1800 636 327 - Customer Service Support |