| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01059-1 |
| Product Name/Description |
Streptex Rapid Latex Agglutination Test. An in vitro diagnostic medical device (IVD)
Product Number: R30950501
Lot Numbers: 1959920, 1987862 and 2106328
ARTG Number: 235676 |
| 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 has confirmed that Extraction Enzyme lots 1960420 and1960621 (contained in the product lots 1959920, 1987862 and 2106328) may provide atypical performance when used with Streptex G Latex reagent. False positive results may be seen within the one minute reaction time detailed in the Instruction for Use. Continued use of these lots of extraction enzyme with G latex reagent (only) may result in incorrect results reporting. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are to inspect stocks and remove from further use all units from the affected batch numbers. Complete the Facsimile Reply Form supplied with the customer letter and fax it to the sponsor for a credit note will be issued.
Requirement for a review of patient results should be at the discretion of the laboratory director.
This action has been closed out on 11/07/2019 |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |