| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00736-1 |
| Product Name/Description |
VITROS Chemistry Products Na+ Slides. An in vitro diagnostic medical device (IVD)
Product Code:8379034
Affected Generations: GENs: 8, 13, 14, 16, 17, 18
Expiry Dates: 01-Nov-2018 through 01-Nov-2019
ARTG Number: 232249
(Ortho-Clinical Diagnostics Australia Pty Ltd - Clinical chemistry electrolyte IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics Australia has identified the potential for positively biased sample results to occur when using certain VITROS Na+ Slides. Results for serum/plasma and urine samples obtained using impacted VITROS Na+ Slides may be positively biased and quality control fluids may be outside of the expected ranges. The amount of bias in the VITROS Na+ method is dependent upon multiple sources of variability.
Two separate issues have been identified:
- VITROS Na+ Slides, GENs 8 & 13: Positively biased urine sample results; and
- VITROS Na+ Slides, GENs 13, 14, 16, 17 & 18: Positively biased serum or plasma sample results. |
| Recall Action |
Recall |
| Recall Action Instructions |
For VITROS Na+ Slides, GENs 8 & 13:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing.
For VITROS Na+ Slides, GENs 14, 16, 17 & 18:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type.
- It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met:
1. Calibration is successful and Quality Control results are within acceptable limits; and
2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory.
If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the physician for all previously reported Na+ results that are likely affected where applicable.
This action has been reviewed and closed out. |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |