Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20813 |
| Brand Name: | VITROS Chemistry Products CRP Slides |
| Model: | |
| Affected: | Product Codes: 1926740 - 10758750000296, 8097990 - 10758750004355, GENs: 3, 11, 12, 30 through 36 |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/o Quigg Partners Level 7, 36 Brandon Street Wellington 6011 |
| Contact Information: | 0800 402 899 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Issue: | Investigation confirmed 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 type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/11/2016 |
