| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00317-1 |
| Product Name/Description |
EliA Intrinsic Factor Well. An in vitro diagnostic medical device (IVD)
Catalogue Number: PU14566801
Lot number: 0015
Expiry date: 31/01/2019
ARTG: 229585
(Abacus dx - Clinical chemistry autoimmune IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
A malfunction of EliA Intrinsic Factor Well has been discovered in EliA Intrinsic Factor Well lot 0015. A customer complaint reported erroneous test results on one single carrier of EliA Intrinsic Factor Well (14-5668-01) lot 0015. Internal investigation by Phadia AB indicated that no antigen solution was dispensed during EliA well coating for a part of the lot.
The described problem could cause erroneous test results. An erroneous test result means that the reported value will be lower than the real value for the patient sample tested, causing false negative results.
To date, there have been no reports of patient injury as a result of this issue.
No other lots of EliA Intrinsic Factor Well are affected. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abacus is advising customers to inspect stock immediately and quarantine any stock of Lot # 0015 to prevent further use. Customers should record the quantity in quarantine on the Customer Reply Form provided with the Customer Letter. Once the form is returned, Abacus will provide users with instructions to destroy or return the quarantined product.
This action has been closed out on the 08/11/2018. |
| Contact Information |
1800 222 287 - Abacus |