| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00004-1 |
| Product Name/Description |
VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)
Unique Device Identifier Number: 10758750004812
Product Code: 8379034
Generation (GEN): 1 through 6, 30 through 40, 44 through 49
Expiry Dates: 01 Jan 2017 through 01 Jun 2018
ARTG Number: 232249 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
An issue has been identified where there is a potential for biased results to be generated over the 10 day on-analyzer limit when using VITROS Na+ Slide cartridges warmed between 1½ to 8 hours prior to being placed on the analyser. It has been determined that cartridges require a minimum of 8 hours of warm up at room temperature to help ensure the slides have acceptable performance throughout the 10 day on-analyser storage limit. This issue affects all expired, in-date GENs, and future product until further notice. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical Diagnostics is advising customers to store cartridges at room temperature for a minimum of eight (8) hours prior to calibration. Customers who have discarded cartridges will have their account credited or be sent a replacement.
This action has been closed out on 27/09/2018 |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |