| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00238-1 |
| Product Name/Description |
Alinity m System. An in vitro diagnostic medical device (IVD)
List Number: 08N53-002
ARTG 206870
(Abbott Australasia Pty Ltd Molecular Division - Instrument/analyser IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Abbott has identified a defect concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System.
The Alinity m System camera detects whether tubes are “capped.” If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message “Error – 6013: Has cap, no retention bar.”
There is no impact to patient results. However, this issue may cause a potential major delay in results (= 3 days).
The customer letter provides several options to resolve error code 6013 if it occurs when uncapped sample tubes are present on the sample rack.
No adverse events related to these issues have been reported in Australia to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Until a software update is available, customers are provided several options to resolve error code 6013 if it occurs when uncapped sample tubes are present on the sample rack.
1. Aliquot the sample into another tube permitted by the assay package insert and ensure the sample tube label requirements in Appendix A are met.
2. Cover coloured portion of tube label that is present in the Keep-Out Zone, depicted in Appendix A, with white opaque material (e.g. white sticker) where the barcode is located. Avoid covering any needed sample information when applying an additional sticker to the sample tube.
3. Reach out to manufacturer of the tube that is triggering the error to discuss alternative tube types that meet the specifications documented within the Abbott assay specific package insert and do not have colour within the required colour free space (Keep-Out Zone) as depicted in Necessary Action #2 and provided image in Appendix A. |
| Contact Information |
1800 816 696 - Abbott Customer Support |