| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00326-1 |
| Product Name/Description |
VITROS Chemistry Systems. An in vitro diagnostic medical device (IVD).
VITROS 4600 Chemistry System & VITROS 5600 Integrated System
Software Version 3.2 & Below
Product Codes: 6802445 & 6802413
VITROS 5,1 FS Chemistry System
Software Version 2.8 & Below
Product Codes: 6801375 & 6801890
Assay Data Disk (ADD)
All DRV versions that support product within expiry dating
Product Code: 6801876
ARTG number: 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/04/2015 |
| Responsible Entity |
|
| Reason/Issue |
Ortho-Clinical Diagnostics (OCD) has identified instances where the VITROS System allowed urine samples for assays that required acidified pre-treatment to be metered from the same sample container as assays that required no pre-treatment when the sample was programmed. The anomaly occurs when manually programming urine samples or using a downloaded sample program from a Laboratory Information System (LIS) and the sample program contain assays requiring sample pre-treatment and assays requiring no sample pre-treatment.
If this anomaly occurs, it is possible for VITROS Systems to process urine samples without the proper pre-treatment, potentially leading to biased patient results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The mitigation to this anomaly is currently under development. OCD will issue a follow up notification upon availability of the software update. OCD is providing users with temporary work around instructions and advising users that for urine samples that require pre-treatment to place each of the pre-treated samples in a separate container and manually program the individual samples. Also, OCD is asking users to discuss concerns regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action. This action has been closed-out on 04/08/2016. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services |