| TGA Action ID |
RC-2025-RN-01003-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Pastorex Meningitis. An in vitro diagnostic medical device (IVD).
Catalog Number: 61607
UDI: 03610520002131
Lot Numbers: 64653198, 64670371, 64679058, Higher batches until resolution
Expiry Dates: 03/03/2026-, 22/04/2026, 10/06/2026 |
| ARTG Number |
206926 |
| Unique Device Identifier (UDI) |
03610520002131 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Bio-Rad has identified a risk of false positive result with the Neisseria meningitidis C latex reagent from the kit Pastorex Meningitis (complete kit #61607).
The other reagents of the Pastorex Meningitis kit remain non-affected, and perform as expected to identify other serogroups of Neisseria meningitidis, Streptococcus pneumoniae, group B Streptococcus and Haemophilus influenzae type b. |
| Instructions for Customers/Users |
Customers should:
· In case of positive Neisseria meningitidis C result (agglutination), confirm the serogrouping of the N. meningitidis strain, as recommended by the WHO (WHO guidelines on meningitis diagnosis, treatment and care, 2025).
· As indicated in the Instructions for Use (IFU) section 7.2.2 Isolated Bacterial Strains Grouping Procedure, prior to performing the test, ensure presumptive identification is checked with gram staining followed by oxidase or catalase testing. Then proceed to Pastorex Meningitis testing with the corresponding latex reagent(s). Confirm the identification of the bacterial species using conventional biochemical testing.
Bio-Rad will add an orange warning sticker to future affected batches, indicating that the product is impacted by this Market Action and providing information to download the Market Action Letter.
This action has been closed out on 02/04/2026 |
| Action Commencement Date |
16/12/2025 |
| Responsible Entity |
|
| Contact Information |
0299142800 - Bio-Rad Technical Support |