| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00398-1 |
| Product Name/Description |
Trinder tests on Roche Analysers – Hitachi 902, COBAS c111, COBAS c311/501/502/701/702 & COBAS INTEGRA 400 plus/800. An in vitro diagnostic medical device (IVD)
· CREA plus,
· CREP2,
· LACT2,
· Lactate,
· GLU,
· TRIGL/TG,
· TRIGGB,
· TRIG/GB,
· CHOL/CHOL2,
· HDL-C plus 3rd generation/HDLC3,
· LDL_C plus 2nd generation/LDL_C, UA2/UA plus
ARTG: 174906, 174908 & 174909 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
New interference claims for Trinder tests have been verified by Roche internal studies.
Trinder tests measured in samples which contain NAC, NAPQI, and Metamizole may show inaccurate results. The severity depends on the clinical situation and the therapeutic state of the patient. It is Good Clinical Practice not to take blood from a patient immediately after administering medication, except in the case of therapeutic drug monitoring. Nevertheless under certain, rare circumstances there is insufficient time between the administration of a drug and blood sampling, which may lead to accuracy issues with the Trinder tests.
Roche has identified:
1. Falsely low CREA plus results for patients with a toxic level of Acetaminophen under treatment with N-acetylcysteine (NAC).
2. Falsely low results of CREA plus after intravenous injection of Metamizole.
The CREA plus results were below the measuring range, while plausible results were obtained with the CREA Jaffé method. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Laboratories are advised to be aware that the recovery of Trinder tests may be falsely low when the blood sample is taken while levels of NAC, NAPQI, and Metamizole are still present.
This action has been closed out on 12/10/2018 |
| Contact Information |
1800 645 619 - Roche Diagnostics National Support Centre |