| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01017-1 |
| Product Name/Description |
Synchron Systems Enzymatic Creatinine (CR-E) and Uric Acid (URIC) Reagents. An in vitro diagnostic medical device (IVD)
Product Codes: A60298 (CR-E),
All Lot Numbers are affected
ARTG Numbers: 213984 and 222819 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter has confirmed that N-Acetyl Cysteine (NAC) used in the treatment of acetaminophen overdose may cause assay interference when administered in therapeutic concentrations with assays using the Trinder chemical pathways; Enzymatic Creatinine (CR-E) and Uric Acid (URIC).
NAC interference may lead to falsely low results for uric acid and creatinine in patients who are concurrently being treated for acetaminophen overdose with NAC. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is amending the INTERFERENCES section of the Chemistry Information Sheets to include N-Actel Cysteine. There is no requirement to review previously generated results. This action has been closed-out on 04/03/2016. |
| Contact Information |
1800 060 661 - Customer Support Centre |