| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01579-1 |
| Product Name/Description |
Architect Active-B12 Reagent Kit. An in vitro diagnostic medical device (IVD).
List Numbers: 3P24-25, 3P24-35
Lot Numbers: 10533UP00, 15034UP00
Expiry: 29 May 2017
ARTG Number: 188927 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Diagnostics has identified a lot specific stability issue with two reagent lots 10533UP00 and 10534UP00. As the reagent ages, Relative Light Unit (RLU) values for the calibration curve will decrease causing patient results calculated from this depressed curve to over-recover, potentially resulting in falsely elevated patient results. Controls may not reflect reagent instability as recalibration may result in control values within acceptable ranges.
Abbott studies have determined the worst case magnitude of elevation to be up to 30% for Active-B12 concentrations close to 20 pmol/L and up to 20% for concentrations close to 30 pmol/L. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott is advising users to discontinue use and immediately destroy any remaining inventory of the affected lots. The customer letter provided to users is to be reviewed with the Medical Director to determine if a review of results previously generated with the affected lots is required.
This action has been closed out on 25/10/2018 |
| Contact Information |
1800 816 696 - Abbott Customer Support |