| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00081-1 |
| Product Name/Description |
Glucose-6-Phosphate Dehydrogenase. An in vitro diagnostic medical device (IVD).
(quantitative kit used for determination of G-6-PDH in blood)
Product Code: 345A
Lot Number: F117009
Expiry: 4 April 2018
ARTG Number: 203621 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/01/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, Trinity Biotech, has identified a potential for misdiagnosis with lot F117009. An investigation identified that this lot displays a level of accuracy variation outside the historical QC product release process control charts for normal range controls, despite falling within the QC acceptance specification. Investigation testing has shown that there is objective evidence that the accuracy issue affects the normal patient range and not the deficient range with a potential health hazard of a false positive result (normal patient diagnosed as deficient) or an invalid test result occurring. |
| Recall Action |
Recall |
| Recall Action Instructions |
Immuno is advising customers to immediately discontinue use of the affected lot and destroy any remaining product. Laboratories are to consider the need to review results previously generated with the affected lot. Immuno will organise replacement kits.
This action has been closed out on 19/11/2018 |
| Contact Information |
1800 252 215 - Immuno |