| TGA Action ID |
RC-2026-RN-00926-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Xpert MRSA/SA SSTI. An in vitro diagnostic medical device (IVD).
Batch Number: 1001489295
Part Number: GXMRSA/SA-SSTI-CE
Lot Number: 17701
Expiry Date: 04/07/2027 |
| ARTG Number |
242177 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Internal testing identified the occurrence of false-negative results in positive samples tested using GXMRSA/SA-SSTI-CE batch 1001489295 (Lot No 17701).
False-negative results, such as MRSA NEGATIVE/ SA POSITIVE or MRSA NEGATIVE/ SA NEGATIVE, may contribute to inappropriate or delayed treatment. In some cases, this could result in progression of infection, potentially including bloodstream infection and sepsis. |
| Instructions for Customers/Users |
Customers should:
1. Stop using any GXMRSA/SA-SSTI batch 1001489295 (lot 17701) kits at their facility and dispose of the remaining affected product
2. Complete the Customer Response Form to acknowledge receipt and request replacement product.
3. As with all questionable negative or questionable positive results, please report to Cepheid Technical Support for investigation and the TGA via a Medical Device Incident Report. |
| Action Commencement Date |
10/11/2026 |
| Responsible Entity |
|
| Contact Information |
1800 130 821 - Cepheid Holdings |