| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00361-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products NT-proBNP Reagent Pack. An in vitro diagnostic medical device (IVD)
Unique Device Identifier Number: 10758750002061
Product Code: 6502156
Lot Numbers: 1570 (exp. 22 Mar 2017), 1580 (exp. 13 Apr 2017), 1590 (exp. 27 Apr 2017) and 1620 (exp. 06 Jul 2017)
ARTG Number: 245492 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
It has been confirmed that some lots of VITROS NT-proBNP Reagent Packs exhibited the potential for an increased frequency of calibration failures, with an unexpected increase in signal for the Level 1 calibrator, potentially causing a failure of the calibration parameters. Preliminary testing has indicated that the calibration failure is related to a component of the VITROS NT-proBNP Reagent Pack and is not associated with the VITROS NT-proBNP Calibrators. Please note that investigations have confirmed that the increase in signal does not affect sample results (i.e., quality control or patient samples) within the 28 day calibration cycle. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical Diagnostics (Ortho) is advising users that they will be sent the revised Master Calibration data to ensure successful future calibrations. In the interim, users are requested to refer to the workaround details contained in their recall notifications. Users (of Lots 1580, 1590 and 1620) who experience this issue and who no longer wish to use the affected products can have the option of having their accounts credited for the product/s discarded.
This action has been closed out on 13/09/2019 |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |