| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00844-1 |
| Product Name/Description |
Synchron Systems Salicylate Reagent. An in vitro diagnostic medical device (IVD)
Reference Number: 378194
All Lots
ARTG Number: 185654 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
As a result of internal investigations, Beckman Coulter has identified temozolomide, an oral antineoplastic drug used to treat certain types of brain cancers, as a potential source of interference with Synchron Salicylate reagent (SALY).
- Temozolomide concentrations of 40 mg/L or greater may cause a negative bias in salicylate test results of up to -22%.
- The half-life of temozolomide is approximately 1.8 hours, with the active half-life of the metabolite being slightly longer. The probability of an erroneous patient result will be dependent upon the times of administration and dosages of both drugs, salicylate & temozolomide. Longer intervals of time between administration of the drugs and the testing will reduce the probability and severity of harm. Lower doses of either drug will also reduce the severity of harm. The worst case scenario only occurs if a patient that is overdosed on salicylates is tested within a short period of time after receiving a high dose of temozolomide. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
No immediate action is required by laboratories other than being aware of this issue as the IFU is being updated. Beckman Coulter is not recommending a retrospective review of prior test results.
This action has been closed out on the 11/10/2018. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |