| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00731-1 |
| Product Name/Description |
MULTIGENT Creatinine (Enzymatic) assay. An in vitro diagnostic medical device (IVD)
List Number: 8L24-31
Lot Numbers: 60335Y600 and 60382Y600
List Number: 8L24-41
Lot Number: 60334Y600
Expiry Date: 28 Feb 2018
ARTG Number: 203299 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer Sentinel has confirmed a performance issue with three specific lots of MULTIGENT Creatinine (Enzymatic) reagent which may result in Quality Control values shifting out of acceptable ranges or erratic patient results, and this issue is not resolved through recalibration.
Sentinel has determined that although the probability of occurrence is remote, a potential delay may exist in the generation of patients' results due to Quality Control values falling outside of expected ranges. Internal investigations made on Quality Controls showed a variability from -26% to +4% for serum samples and from -20% to +4% for urine samples. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott is advising users to discontinue use of the impacted lots immediately and destroy any remaining inventory of impacted lots according to their laboratory procedures. If you have an alternate reagent lot available in inventory, switch to this alternate lot, or use a new lot provided. The customer letter is to be reviewed with the laboratory Medical Director.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 816 696 - Abbott Customer Service |