Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 15748 |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products ALT slides |
| Model: | Product Code: 1655281 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products CK Slikes |
| Model: | Product codes: 8479396, 8478034 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics c/- Johnson & Johnson |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products LDH Slides |
| Model: | Product Code: 8384489 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products hsCRP Reagent |
| Model: | Product Code: 6801739 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products THC Reagent |
| Model: | Product Code: 6801994 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products TIBC Kit |
| Model: | Product Code: 8867541 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products METD Reagent |
| Model: | Product Code: 6801996 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Brand Name: | Ortho-Clinical Diagnostics VITROS Chemistry Products CRBM Slides |
| Model: | Product Code: 8892382 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Ortho-Clinical Diagnostics c/- Johnson & Johnson 13A Gabador Place Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 800 705 |
| Manufacturer: | Ortho-Clinical Diagnostics Inc |
| Issue: | Ortho-Clinical Diagnostics, Inc. (OCD) became aware of discrepancies between the default dilution factors entered on the VITROS® System from Calibration Diskettes (Cal Disk) and Assay Data Disks (ADD) DRV 5740 and below versus our claims support data. The revised default dilution factors are associated with on-board dilutions performed on VITROS® System. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 27/11/2013 |
