| TGA Action ID |
RC-2026-RN-00903-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Syva EMIT II Plus Barbiturate Assay. An in vitro diagnostic medical device (IVD).
Catalog Numbers: 10445422, 10445423, 10445424, 9D029UL, 9D039UL, 9D129UL
Lot Numbers: W1, W2, W2A & future lots
Expiry Date:19-Mar-2028, 22-Jun-2028 |
| ARTG Number |
182221 |
| Unique Device Identifier (UDI) |
00842768001871, 00842768014352, 00842768001888 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Following investigation of customer complaints, Siemens has confirmed that certain compound concentrations listed in the Syva EMIT II Plus Barbiturate Assay Instructions for Use (IFU) require revision. The IFU will be updated with revised concentrations of certain compounds that produce responses approximately equivalent to the specified secobarbital cutoffs. This information describes the assay’s response to individual barbiturate compounds and supports interpretation of test results.
In the worst case, this could result in falsely positive or negative barbiturate urine screen results. |
| Instructions for Customers/Users |
Customers are to:
- Review the customer letter and revised concentration values.
- Discuss with their Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
- Retain this information until the Syva EMIT II Plus Barbiturate Assay IFU has been updated. |
| Action Commencement Date |
10/11/2026 |
| Responsible Entity |
|
| Contact Information |
1800 310 300 - Siemens Customer Care Center |