| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01414-1 |
| Product Name/Description |
Foetal Haemoglobin Monoclonal Antibody (HBF-1). An in vitro diagnostic medical device (IVD)
Catalogue Number: MHFH01 and MHFH04
Lot Number: 1848553A and 1781432A
Expiry date: 31 January 2019
ARTG Number: 212744 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Life Technologies Australia have received four (4) customer complaints worldwide on multiple lots pertaining to poor antibody detection whereby customers reported little to no antibody staining. In the complaints received, customers identified a reduction in the intensity of staining, unequal staining, and in some instances, may have observed a reduction or shift in the positive population peak for foetal haemoglobin. With the use of controls, the end user can identify a product deficiency before diagnostic samples are analysed. Failure of the positive controls to perform as expected is a basis for discarding test results and repeating the test.
There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
Life Technologies is advising users to inspect stock and discard any remaining units of the affected lot number. There is unaffected stock available.
This action has been closed out on 3/09/2018. |
| Contact Information |
1800 636 327 - Life Technologies Australia Pty Ltd |