| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00577-1 |
| Product Name/Description |
Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. An in vitro diagnostic medical device (IVD)
Product Codes: OSR6X204, OSR6X16, OSR6X118, OSR6X98, OSR6X93, OSR6X30
All Lot Numbers
ARTG Numbers: 200018, 200015 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is a possibility that drug interferences from administration of Metamizole (Dipyrone) to patients may generate false low results.
Metamizole (Dipyrone) has been identified as an interferent which may cause false low results in certain assays. This is a previously undocumented interferent.
These interferences are based on a chemical interaction with the Trinder reaction, similar to NAC interference previously identified by Beckman Coulter and may result in an error in diagnosis or patient management.
No customer complaints have been received for this particular issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter is providing users with updated Instructions for Use (IFU) to follow in order to avoid any potential interferences.
A review of previously generated patients results is at the discretion of the Laboratory Director.
This action has been closed out on 08/11/2018 |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |