| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01176-1 |
| Product Name/Description |
SpermMar IgA (Fertipro) (Test for sperm antibodies against IgA)
BatchNumber: FP14A09, FP14A10
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
28/11/2014 |
| Responsible Entity |
|
| Reason/Issue |
Fertipro has informed that some customers have reported reduced motility in certain semen samples when using the updated SpermMar IgA test (Brown Beads). This reduced motility may result in a lower proportion of free moving sperm and affect the interpretation of the results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are instructed to stop using and destroy the affected batches. Fertipro is currently working on optimising the buffer of the reagent to avoid this reduction in motility. The optimised reagent will be included from batch FP14A11 onwards. Users are advised that the need for a look back at previously reported results be discussed with their clinical/laboratory director. This action has been closed-out on 01/03/2016. |
| Contact Information |
1800 252 215 - Immuno |