| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00964-1 |
| Product Name/Description |
ID NOW Instrument. An in vitro diagnostic medical device (IVD)
Part Number: NAT-000, NAT-000S
All serial numbers
ARTG 225546
(Abbott Rapid Diagnostics Pty Ltd T/A Alere - Instrument/analyser IVDs) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/11/2023 |
| Responsible Entity |
|
| Reason/Issue |
When using the current version of ID NOW software, version 7.0, users can run the ID NOW COVID-19 2.0 and ID NOW Influenza A&B 2 test sequentially, from one patient sample.
Some customers have reported an increase in Influenza B false positive test results when using the device in this manner.
In house testing has confirmed ID NOW Influenza A & B 2 Influenza B Specificity remains within label claims (97.1% with a 95% confidence interval of 95.9%-98.1%) when using sequential workflow, but due to an increase in customer complaints, a software modification has been implemented in software version 7.1 to mitigate the potential occurrence of false positive Influenza B test results. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Distributers are to:
-Compile a traceability report of ID NOW Instrument to identify all users with name, address, contact information that have received the product.
-Notify all identified users of the Product defect correction.
-Place free of charge orders on ID NOW Software Upgrade kit (part number NAT-300) based on orders received by customers.
15/11/2023
-Customers are to upgrade ID NOW Instrument software to software version 7.1 using the ID NOW Software Upgrade kit that Abbott will send using the information provided on the returned Acknowledgement Form.
This action has been closed out on 03/04/2024 |
| Contact Information |
07 3363 7129 - Abbott Rapid Diagnostics Pty Ltd |