| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00480-1 |
| Product Name/Description |
Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid & Salicylate Reagents. An in vitro diagnostic medical device (IVD)
Reference Numbers:
467825 - Cholesterol (CHOL)
A60298 - Enzymatic Creatinine (CR-E)
A15625 - HDL Cholesterol (HDL)
A95550 - Lactate (LACT)
445850 - Triglyceride (TG and TG-B)
442785 - Uric Acid (URIC)
378194 - Salicylate (SALY)
All Lots
ARTG Number: 185654 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/04/2017 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has identified the drugs Metamizole (Dipyrone), Sulfasalazine and Sulfapyridine as potential sources of interference when using Synchron Systems Cholesterol, Creatinine, HDL Cholesterol, Lactate, Triglyceride, Uric Acid and Salicylate Reagents. With the administration of these drugs, the effects to patient analytes are:
- Metamizole (Dipyrone) – may generate false low Cholesterol, Enzymatic Creatinine, HDL Cholesterol, Lactate, Triglycerides and Uric Acid results.
- Sulfasalazine – may generate false high Salicylate results.
- Sulfapyridine – may generate false low Salicylate results.
Information regarding interference with these drugs will be added to the Chemistry Information Sheets (CIS) for the respective products. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is advising users of additions to the Interferences section of the respective Chemistry Information Sheets (CIS), as follows:
- For CHOL, CR-E, HDL, LACT, TG, TG-B and URIC*: Venipuncture immediately after or during the administration of Metamizole (Dipyrone) may lead to falsely low results for [analyte name*]. Venipuncture should be performed prior to the administration of Metamizole.
-For SALY: Patients treated with Sulfasalazine may generate a false high result for Salicylate.
Patients treated with Sulfapyridine may generate a false low result for Salicylate.
The CIS will be updated on the Beckman Coulter website's Technical Documents webpage.
This action has been closed out on 14/11/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |