| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00806-1 |
| Product Name/Description |
iChem Velocity Urine Chemistry Strips. An in vitro diagnostic medical device (IVD)
Lot Number: 7204081A
Expiry Date: 02/2016
Vials numbered 14996 through 15859 (except 15315 and 15316)
ARTG Number: 177551 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Iris International has determined that sample probe misalignment or bending on the iChemVELOCITY may lead to a remote possibility of false negative results due to inadequate strip dosing. The manufacturer'sinvestigation was initiated based on customer complaints for control failures.
Iris International has become aware of a manufacturing defect where a glucose pad was placed in the location intended for the protein pad on a subset of vials numbered 14996 through 15859 (with the exception of vials 15315 and 15316 within that series) within lot number 7204081A.
The manufacturing defect will cause:
· Consistent false negative results in the presence of proteinuria.
· False positive urine protein results may occur when patient specimen contains glucose.
· Quality control failures for protein results. |
| Recall Action |
Recall |
| Recall Action Instructions |
Beckman Coulter is advising users to inspect and discard any remaining inventory of affected vials.
Beckman Coulter recommends consulting with the Laboratory Director to determine if a review of previously reported results is required. This action has been closed-out on 18/08/2016. |
| Contact Information |
1800 060 880 - Beckman Coulter |