Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18632 |
| Brand Name: | Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reaction |
| Model: | Multiple catalogue numbers |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Roche Diagnostics (NZ) Ltd 15 Rakino Way Mt Wellington AUCKLAND 1644 |
| Contact Information: | 0800 363 622 |
| Manufacturer: | |
| Issue: | Due to information received from the field, the potential interference of Sulfasalazine and Sulfapyridine in the Alanine Amino-Transferase (ALT) tests was investigated. The interference through Sulfasalazine and Sulfapyridine was checked for all tests using NAD(H) or NADP(H). This study was done with the following strongly elevated plasma concentrations which correspond to the CLSI-Guideline EP-7-A2: - 754 micromol/L Sulfasalazine (300 mg/L) - 1.2 mmol/L Sulfapyridine (299 mg/L) The interference depends on the pharmacokinetic and the clinical status of the patient (e.g. liver and kidney function, bowel resection etc.), which makes it impossible to provide exact information about serum drug concentration and half time. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 10/6/2015 |
