| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00817-1 |
| Product Name/Description |
Epiclone Anti-M Blood Grouping Reagent. An in vitro diagnostic medical device (IVD)
Product Item Number: 00980501
Pack Size: 1 unit per pack
Lot Numbers: 009817001, 009817101 (exp 10/11/17), 009817201 (exp 11/11/17), 009817301, 009817401 (exp 09/12/19) and 009817501 (exp 05/12/19)
ARTG: 225013 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Merck-Millipore has advised Seqirus of an issue with Anti-M Monoclonal Blood Grouping Reagents producing weak or negative testing results when testing M+ red blood cells in line with the method described in the Instructions for Use (IFU).
Seqirus sources these reagents as raw material items, which are then subject to acceptance testing and labelling / packaging and then distributed as Seqirus Epiclone Anti-M. As part of batch release these materials passed all potency and specificity requirements, and there have not been any product technical complaints or market feedback of testing issues regarding these products. |
| Recall Action |
Recall |
| Recall Action Instructions |
Seqirus is advising users to quarantine all affected stock from inventory. Seqirus will arrange collection of affected stock from customers.
This action was closed out on 10/09/2018 |
| Contact Information |
1800 008 275 - Seqirus Pty Ltd |