| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00868-1 |
| Product Name/Description |
Shigella dysenteriae Polyvalent (1 – 10) Agglutinating Serum (reagent intended for the identification of Shigella dysenteriae). An in vitro diagnostic medical device (IVD)
Product Code: R30163701
Carton Lot Number: 1111470
Bottle Lot Number: 1130078
Carton Lot Number: 1236726
Bottle Lot Number: 1297592 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/08/2014 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by the manufacturer has identified that the listed lot numbers of Shigella dysenteriae Polyvalent (1-10) Agglutinating Serum may react with negative isolates, resulting in false positive results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Oxoid Australia Pty Ltd is recalling the affected batches of product. End users are requested to inspect their stocks and remove from further use all units from the above lot numbers. The requirement for review of patient results should be determined by the laboratory director. This action has been closed-out on 03/06/2016. |
| Contact Information |
08 8238 9044 - Oxoid Australia |