| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00463-1 |
| Product Name/Description |
Roche clinical chemistry tests - ALT, AST, CK, CK-MB, GLDH and NH3 using the NAD(H) or NADP(H) reaction
All lots affected
ARTG: 174906
An in vitro diagnostic medical device (IVD)
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/06/2015 |
| Responsible Entity |
|
| Reason/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 µmol/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 |
Recall for Product Correction |
| Recall Action Instructions |
Roche is advising laboratories of the potential drug interference. Test instructions for use are in the process of being updated. This action has been closed-out on 11/08/2016. |
| Contact Information |
1800 645 619 National Support Centre |