| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00648-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products AFP Reagent Packs and Calibrators. An in vitro diagnostic medical device (IVD)
VITROS AFP Reagent Pack
Device Identifier: 10758750006489
Product Code: 1925551
VITROS AFP Calibrators
Device Identifier: 10758750006540
Product Code: 1515154
Lot Number: 1470
Expiry Date: 13 Dec 2016
ARTG Number: 248385 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has become aware of the potential of an inability to obtain a valid calibration when using VITROS AFP Reagent Packs.
Ortho Clinical Diagnostics (Ortho) confirmed that the affected lots exhibited an increase in reaction signal over time. The investigation indicates that there is the potential for sample concentrations to increase during the 28-day calibration timeframe by up to 12% and that the magnitude of the positive bias will decrease as sample concentrations increase. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical is advising users to discontinue use and discard affected lots. If users are able to successfully calibrate and QC results are acceptable, users may continue to use the affected lots until the replacement stock arrives.
Previously reported results are valid, providing that QC results were within acceptable limits. This action has been closed out on 13 Jun 2017. |
| Contact Information |
1800 032 359 - Ortho Clinical Technical Solutions Centre |