| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01146-1 |
| Product Name/Description |
Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)
Abtectcell III% 0.8%
Item Number: 22450201
Lot Number: 2245204
Expiry Date: 26/12/2015
Abtectcell III% 0.8% Bulk Pack
Item Number: 22450205
Lot Number: 2245204A
Expiry Date: 26/12/2015
ARTG Number: 223867 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
This product is a 3 cell screening panel that is used in immunohematology testing to screen patient plasma or serum samples for the presence of clinically relevant red cell alloantibodies for pre transfusion and pre-natal testing.
Cell 2 when tested against weak Anti E controls (i.e. Securacell) during pre-acceptance testing in BioVue and Grifols CAT Platforms, is giving weak or negative reactions and not the expected mid-strength reactions. However, testing in the Bio-Rad (DiaMed) CAT Platform is giving the expected result.
There is a potential risk that undetected weak Anti-E antibody using certain CAT platforms could lead to Delayed Hemolytic Transfusion Reactions (DHTR) for the patient. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor Seqirus is advising the users to inspect stock and quarantine all affected units prior to their return. The sponsor will arrange the replacement of the affected units or return credit. This action has been closed-out on 29/08/2016. |
| Contact Information |
1800 008 275 - Seqirus Customer Service |