| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00749-1 |
| Product Name/Description |
Valproic Acid and Antibiotic TDM Multi-Calibrator. An in vitro diagnostic medical device (IVD).
Reference Numbers: OSR6415 and ODC6413
All Lots
ARTG Number: 200020 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/06/2017 |
| Responsible Entity |
|
| Reason/Issue |
Beckman Coulter is advising of a change in the hazard classification of Valproic Acid OSR6415 and Antibiotic TDM Multi-Calibrator ODC6413. Test results are not affected. Valproic acid (OSR6415) and TDM Multi-Calibrator (ODC6413) are missing required hazard labelling as per Globally Harmonised System of Classification and Labelling of Chemicals (GHS) regulation. Products are incorrectly labelled as non-hazardous instead of hazardous. The change in hazardous information is for the following ingredients: 0.1-1% Vancomycin in Antibiotic TDM Multi-Calibrator; and |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Beckman Coulter has updated the Safety Data Sheet (SDS) for Valproic Acid and Antibiotic TDM Multi-Calibrator and the new Hazardous classification, pictograms and signal word will be displayed in future on the product labels and in the GHS Hazard Classification section of the IFU for each product, namely BLOSR6415 and BLODC6413. In the interim, this information is provided in the customer letter. Users are to share the letter with their local Environmental Health and Safety representative and ensure compliance with local procedures for disposal and handling of Hazardous material.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1800 060 881 - Beckman Coulter Customer Support Centre |