| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01361-1 |
| Product Name/Description |
Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)
Product Item Number: 00980501
Expiry: 11/06/2019
Pack Size: 1 unit per pack
Lot Number: 009817601
ARTG: 225013 (Immunohaematology blood grouping |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Seqirus has received notification that Epiclone Anti M Lot 009817601 is showing false positive M reactions with M Negative control cells in CAT (Column Agglutination Technology) BioVue Cards. Investigational testing by Seqirus suggests that there is an incompatibility between Anti-M Lot 009817601 and the CAT BioVue Cards. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Seqirus is advising customers to only use the product for phenotyping via the Tube method. Users should not continue use of the product with Column Agglutination Technology (CAT) Cards. Seqirus is advising laboratories to perform a review of previous positive reactions obtained where CAT Cards have been used with Epiclone Anti M Lot 00981760.
This action has been closed out on 30/10/2018 |
| Contact Information |
1800 008 275 - Seqirus |