| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01435-1 |
| Product Name/Description |
RE51021 / MuSK-Ab ELISA
Lot EMU124
ARTG number: 210637 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
This notice is to inform you about a recall action for IBL International product IBRE51021 MuSK-Ab ELISA Lot EMU124 with Expiry date 31-10-2018. This action has been undertaken by the Australian distributor Abacus ALS following consultation with the Therapeutic Goods Administration (TGA). No other lot numbers of this product are affected by this recall.
Description of the problem:
The user of this assay may notice that the antiserum (#KEMU521, lot: S882) and assay buffer (#KEMU751, lot: S881) appears contaminated (cloudy and contain particles). This issue is caused by a contamination of lot # EMU124. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users should inspect stocks and quarantine all units of IBRE51021 Lot EMU124, then
complete and return the supplied Reply Form as directed for stock to be recovered and replaced.Complete the Reply Form even if you have no stock which is subject to recall, as Abacus ASL requires this information to reconcile this process.
Retain the letter in a prominent position for one month in case stock is in transit.
If any affected stock has been transferred from your Laboratory to another, immediately let that laboratory know of the recall and inform Abacus ASL.
This action has been closed out on 24/09/2018 |
| Contact Information |
1800 222 287 - Abacus ALS Pty Ltd |