| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00348-1 |
| Product Name/Description |
EliA Sample Diluent
Art. No. 83-1023-01
Lot Numbers: JM3Y, JS0B, JP87, JK5N, JU9C
Bottle Lots: BVXDR/JM3W, BVXDT/JS0A, BVXDS/JP83, BVXDP/JK5M, BVXDU/JU9B
ARTG Number: 229543 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports of instrument malfunctions for Phadia 250 due to deformed bottles in the above-mentioned products and lots. The deformation of the bottle can cause an erroneous volume detection by the instrument, which will result in insufficient aspiration of sample diluent, thus generating insufficient dilution of patient samples. The deformation is described as a flange or brim, located on the inside lower part of the vial opening. The instrument malfunction due to deformed bottles could cause erroneous test results, mainly a false positive, with regard to all EliA assays. The frequency of this bottle defect is very low and not every defective bottle will cause the error. An instrument malfunction caused by deformed bottles will generate the instrument error message “3-145 RIGHT ARM LIQUID DETECTION BELOW LOWER LIMIT with Target 2”. |
| Recall Action |
Recall |
| Recall Action Instructions |
Users are notified to stop using the affected lots and record the lot numbers and quantity of any unused products prior to discarding them. Abacus ALS will organise replacements at no charge. Also, users are advised to discuss the contents of the letter with the Medical Director to ascertain if any further actions are required.
This action has been closed-out on 21/03/2018. |
| Contact Information |
1800 222 287 - Abacus ALS |