| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00623-1 |
| Product Name/Description |
ARCHITECT B12 Reagent kit
7K61-35 lot 53921UI00 (Expiry 20 March 2016)
7K61-25 lot 50957UI00 (Expiry 17 January 2016)
7K61-35 lot 50956UI00 (Expiry 17 January 2016)
UDI Number- Not applicable
ARTG Number: 186731 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Abbott Diagnostics Division has determined that during the manufacture of the ARCHITECT B12 reagent kits (List 7K61) listed below, an incorrect IFU (Instructions For Use) commodity number G3-0354/R04 may have been inserted into the reagent kits. There is no impact to patient safety. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the incorrect IFU is detected, customers are requested to download the correct IFU from the following website located on the ARCHITECT B12 reagent kit label: - www.abbottdiagnostics.com/IFU. This action has been closed-out on 15/08/2016. |
| Contact Information |
1800 816 696 - Abbott Customer Support |