| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00053-1 |
| Product Name/Description |
Technopath Multichem IA Plus, Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3 and Multichem P. An in vitro diagnostic medical device (IVD).
List numbers: 08P86-10, -19; 08P88-10, -11, -12 and 08P90-10
Multiple lot numbers
ARTG 214555
(Abbott Australasia Pty Ltd Diagnostic Division - Multiple clinical chemistry constituent IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
Technopath Manufacturing Ltd has identified an issue with the 8mL Alinity glass vial commodity used to fill Multichem IA Plus controls and Multichem S Plus (Assayed) controls. Some customers have experienced broken vials when receiving or thawing these products. This is a continuation of a previous recall action RC-2023-RN-00800-1.
There have been no reports of adverse events related to this issue in Australia. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The customer letter provides required actions and safety precautions to all laboratory personnel with direct product handling responsibilities.
Upon receiving damaged, broken, leaking vials, customers should contact Abbott Customer Service for assistance with replacement product or credit.
If the product has been forwarded to other laboratories, please inform them of this product defect correction.
Technopath, have a strengthened glass vial design that has now been qualified for use. All future lots will be manufactured using the strengthened vials and will become available through the course of 2024. |
| Contact Information |
1800 816 696 - Abbott Customer Support |