| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01627-1 |
| Product Name/Description |
VITROS Chemistry Products UPRO Slides for measurement of protein in urine (using VITROS 250/350/5,1 FS/4600 and 5600 Systems). An in vitro diagnostic medical device (IVD).
VITROS UPRO Slides GENs 14, 15, 16, 17 & 18
Product Code: 6800120
Expiry Date range: 1 Jan 2017 to 1 May 2018
ARTG Number: 232251 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (Ortho) has identified the potential for biased urine protein results using VITROS UPRO Slides.
The following observations were made when using VITROS UPRO Slides:
-1. Variability GEN to GEN for patient samples. Impact to results: Magnitude of bias is dependent upon the GEN;
-2. Variability in results for random and 24-hour urine samples with low specific gravity. Impact to results: Unexpected increase in the number of results exceeding the reference intervals for random and 24-hour urine samples.; and
-3. Negatively biased results. Impact to results: Negatively biased results versus the Ortho Pyrogallol Red comparative method.
Ortho is providing users with the results of their internal testing that details the levels of bias observed for each of the scenarios above.
GENs 12-18 are affected, however the GEN 12 and 13 product have expired. |
| Recall Action |
Recall |
| Recall Action Instructions |
Ortho is advising users to immediately discontinue using and discard all VITROS UPRO Slides remaining in their inventory. Ortho will credit accounts for any discarded VITROS UPRO Slides and VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Any concerns users may have regarding previously reported urine protein results should be discussed with the Laboratory Medical Director to determine the appropriate course of action. As Ortho is unable to provide replacement VITROS UPRO Slides at present, they recommend laboratories use an alternative method until further notice by Ortho of future product availability. |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |