| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00167-1 |
| Product Name/Description |
Merifluor EBV VCA IgM IFA (an Immunofluorescence Test for the Detection of Antibodies). An in vitro diagnostic medical device (IVD)
Lot Number: EB150G160
Substrate Slide Lot Number: 2921-366
Expiry Date: 30 June 2016
ARTG Number: 214645 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
11/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
A report has been received that the foil pouches for some EBV-NA substrate slides appear to have been damaged, resulting in exposure to moisture and a decrease in slide reactivity/loss of fluorescence. It has also been determined that the desiccant packaged with the compromised EBV-NA Substrate Slides have turned pink, indicating exposure to moisture. The desiccants are typically blue.
Internal testing has demonstrated that the Positive Control tested with an EBV-NA Substrate Slide from a damaged pouch with pink desiccant shows no fluorescence, which is interpreted as an invalid reaction according to the Product Package Insert. There is no impact to patients.
This action was carried out prior to consultation with the Therapeutic Goods Administration (TGA). |
| Recall Action |
Recall |
| Recall Action Instructions |
Bioline is advising users to check the colour of the desiccant prior to use. If the desiccant is pink, the slides should not be used. Blue desiccant pouches can be used to testing if the control results are acceptable. This action has been closed-out on 03/08/2016. |
| Contact Information |
02 9209 4188 - Bioline Australia |