| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01549-1 |
| Product Name/Description |
Homocysteine Enzymatic Assay used on Cobas Integra 400 plus/800 analysers and cobas c 501/502 & 701/702 modules. An in vitro diagnostic medical device (IVD).
Homocysteine Enzymatic Assay (100 tests)
Material Number: 05385415190
Lot Number: 173114
Homocysteine Enzymatic Assay (200 tests)
Material Number: 06542921190
Lot Number: 173121
ARTG Number: 174908 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics’ internal investigations found Homocysteine reagent lots 173114 and 173121 can lead to under-recovery of results in quality controls (QC) and patient samples. The root cause of the issue has been identified to be the instability of the enzyme, Homocysteine S-methyltransferase (HMTase) in reagent R2. Lower recovery of affected reagent lots could lead to false low homocysteine results in the worst case scenario. This could further affect the interpretation of the potential risk of atherosclerosis and lead to a delay in diagnosis of atherosclerosis. However, since homocysteine is used for the estimation of long-term cardiovascular risk (late cardiac events), an adverse event due to this issue is extremely unlikely. |
| Recall Action |
Recall |
| Recall Action Instructions |
Roche is advising customers to immediately discard affected product. Roche will provide unaffected replacement stock. The under recovery issue should be discussed with the medical director to determine whether a look-back is required for previously affected patient results. This action has been closed-out on 26/05/2017. |
| Contact Information |
02 9860 2357 - Roche Diagnostics Australia |