| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00201-1 |
| Product Name/Description |
Thermo Scientific Remel Neisseria meningitidis Poly A-D 2mL and Neisseria meningitidis Group D 2mL. An in vitro diagnostic medical device (IVD)
Catalogue Numbers: R30166601, R30167001
Lot Numbers: 2239498, 2177820, 2239861, 1773410 & 1739963.
ARTG Number: 236824
(Thermo Fisher Scientific Australia & New Zealand - Microbial-isolate agglutination reagent IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/03/2018 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Remel Europe, part of Thermo Fisher Scientific, has confirmed that Remel Neisseria meningitidis Poly A-D (R30166601) and Neisseria meningitidis Group D (R30167001) may fail to agglutinate within the specified minimum reaction time when tested with Group D Neisseria meningitidis bacteria. Continued use of these lots may result in a failure to correctly identify isolates as Group D Neisseria meningitidis bacteria. The product Thermo Scientific Remel Neisseria meningitidis Poly A-D (R30166601) continues to correctly identify Neisseria meningitidis Groups A, B and C. No other batches or pack sizes of this product are affected by this recall. |
| Recall Action |
Recall |
| Recall Action Instructions |
ThermoFisher is advising users to inspect stock and remove all units of the affected batches from further use. Users should complete the Facsimile Reply Form provided with the Customer Letter to arrange for a credit note to be issued.
This action has been closed out on the 22/11/2018. |
| Contact Information |
08 8238 9044 - Customer Service Support |