| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01427-1 |
| Product Name/Description |
VITROS Chemistry Products C-reactive protein (CRP) Slides
Product Codes: 1926740, 8097990
Unique Identification Numbers: 10758750000296, 10758750004355
Affected Generations (GENs): 3, 11, 12, 30 through 36
This issue may affect expired, current (in date) and future product GENs
ARTG Number: 232251 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (Ortho) received reports of positively biased CRP results using VITROS CRP Slides when diluting samples. Investigation undertaken by Ortho identified that samples diluted (3X recommended dilution or higher) using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3 or a low CRP concentration sample had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The magnitude of bias increases as the dilution factor increases. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised to follow the instructions in the customer letter to perform dilutions when processing samples above the measuring range for CRP. VITROS CRP Slides Instructions for Use (IFUs) will be revised to include the additional instructions to follow when diluting samples with results above the measuring range. Discuss any concerns regarding previously reported CRP results with the Laboratory Medical Director to determine the appropriate course of action. The results from this or any other diagnostic test should be used and interpreted only within the context of the overall clinical picture. This action has been closed-out on 26/05/2017. |
| Contact Information |
1800 032 359 - OrthoCare Technical Solutions Centre |