| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01144-1 |
| Product Name/Description |
VITROS 4600 Chemistry System and VITROS 5,1 FS Chemistry System. An in vitro diagnostic medical device (IVD)
VITROS 4600 Chemistry System, software Version 3.2 & Below
Product Code: 6802445
VITROS 5,1 FS Chemistry System, software Version 2.8 & Below
Product Codes: 6801375 and 6801890
ARTG Number: 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
20/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (Ortho) recently identified that under very specific conditions, the temperature in the MicroWell subsystem (included on other VITROS Systems) may potentially be out of range without the system properly alerting the operator. Although the VITROS 4600 System and VITROS 5,1 FS System do not include a MicroWell subsystem, it utilises the same software as other VITROS Systems. Ortho has estimated that there is a less than 1 in 14 million possibility that this anomaly could occur in the MicroSlide or MicroTip subsystems included on Chemistry Systems, based on e-Connectivity data.
In the low likelihood that the anomaly occurs (<1 in 14 million), it is possible to process samples outside of the proper temperature range where results will not be flagged with an “IT” (incubator temperature) result code. This anomaly has never been known to result in a biased result, and it is not reasonable to expect that a biased result would ever occur due to the anomaly. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho has determined that the anomaly is due to an error in the software code. The resolution is currently under development and will be provided in a future version of software.
Due to the low likelihood for this anomaly to occur, Ortho is not requiring users to monitor the temperature of their system. However, users may choose to verify that their system is within the proper temperature range. This action has been closed-out on 29/08/2016. |
| Contact Information |
1800 032 359 - Technical Solutions Centre |