| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01103-1 |
| Product Name/Description |
Remel Wellcolex Colour Shigella Reagent. An in vitro diagnostic medical device (IVD)
Product Code: R30858401
Lot Numbers: 1991413, 2130764, 2110576, and 2143554
ARTG Number: 236824 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Thermo Fisher Scientific has confirmed that specific lots of Remel Wellcolex Colour Shigella Reagent may not
agglutinate in the presence of positive cultures. A negative result indicates that the organisms under test do not belong to the serotypes of Shigella species covered by the reagents.
Latex Reagent 2 is used to identify common serotypes of S. dysenteriae and S. boydii. Continued use of these lots may result in a failure to correctly identify S. boydii. S.dysenteriae results are unaffected. Latex Reagent 1 continues to perform correctly and will identify common serotypes of S. sonnei and S. flexneri. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Inspect your stocks and remove from further use of all units from the impacted batch number, then complete and return the Facsimile Reply Form supplied with the customer letter.
2. If any recalled stock has been transferred from your laboratory to another, inform that laboratory of the recall action.
This action has been closed out on the 26/09/2018. |
| Contact Information |
1300 735 292 - Thermo Fisher Scientific Australia Customer Service |