| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00955-1 |
| Product Name/Description |
MULTIGENT Ammonia Ultra Reagent. An in vitro diagnostic medical device (IVD)
List Number: 6K89-30
Lot Number: 50083Y600
Expiration Date 31 Jul 2016
ARTG Number: 203299 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Due to a manufacturing issue with MULTIGENT Ammonia Ultra Reagent, list number 6K89-30, lot 50083Y600 are being removed from use. This lot is producing results below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. Quality Control results are not affected.
Complaints relating to out of range patient results have been confirmed through internal testing as no measurable Ammonia values were obtained for samples tested per package insert instructions.
A review of complaint data for the impacted lot of Ammonia also indicates there is potential for lower than expected results to be generated, however, this has not been confirmed during internal testing.
Based on testing of all in-date lots no other reagent lots or sample tube types are known to be impacted. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are requested to inspect their stock and destroy any inventory affected by this recall.
Abbott is advising users to follow laboratory protocol regarding the review of previously generated patient results. This action has been closed-out on 26/08/2016. |
| Contact Information |
1800 816 696 - Customer Support |