| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01547-1 |
| Product Name/Description |
VITROS Chemistry Products PHYT Slides used on VITROS 250/350/950/5,1 FS/4600/5600 Systems. An in vitro diagnostic device (IVD).
VITROS Chemistry Products PHYT Slides
Product Code: 8298671
Lot Numbers: all current (in date) lots
Calibration Diskette (Product Code: 8716607) & Assay Data Diskette (ADD) (Product Code: 6801876) versions (DRV) 5909 and below
ARTG Number: 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho is providing additional information for a product correction notification that was issued in December 2015 (RC-2016-RN-00017-1) regarding the clarification of operator actions for wash errors. Since that time, Ortho has been monitoring the occurrence of U90-382 or 6LU condition codes associated with wash errors and observed that wash errors were occurring at a higher than expected rate for VITROS PHYT Slides. It was determined that VITROS Systems could sometimes identify false wash errors. If a U90-382 or 6LU code is generated, the VITROS System suppresses the result and “No Result” is reported (and review of previously reported results is not necessary).
Ortho has identified an improvement to the wash algorithm that will help reduce false wash errors while not compromising the detection of true wash errors. This improvement involves a change to the Magenta Wash Tolerance (MWT) limit and will be implemented on Calibration Diskette/Assay Data Diskettte (ADD) DRV 5910 and above. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho is advising users to install Calibration Diskette or ADD DRV 5910 or above on their VITROS system. An automatic download will be available for e-Connected systems as of December 2, 2016. The Calibration Diskette and/or ADD will also be sent to the customer's facility when available. After loading DRV 5910 (or above) for the first time, VITROS PHYT Slides will un-calibrate and will require recalibration. In the interim, the product can continue to be used.
This action has been closed out on 31/10/2018 |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |