| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00629-1 |
| Product Name/Description |
DELFIA Xpress PlGF Kit
Catalogue numbers: 6007-002C
Product Lot numbers: 1063782701
ARTG Number: 198244 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/07/2015 |
| Responsible Entity |
|
| Reason/Issue |
Perkin Elmer has become aware that the stability of the PlGF Calibrators lot 637341 is impaired. The stability issue is limited to one lot of PlGF Calibrators. Due to the impaired stability a decreasing trend in the signal level measured for the PlGF Calibrators occurs; the signal level of the PlGF Calibrators lot 637341 has decreased an average of 20% since release. The signal decrease results in the measured PlGF concentrations for the QC controls and patient samples will be falsely high, expected increase is approximately +20%. Perkin Elmer investigations have identified the impaired stability of the PlGF Calibrators is due to an issue in the quality of a single batch of the raw material used in the manufacture of the PlGF Calibrators. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Perkin Elmer is requesting the customers to check their inventory, immediately discontinue use and destroy all the affected DELFIA Xpress PlGF kit lots. PerkinElmer will replace all DELFIA Xpress PlGF Kits of the designated lots in the inventory. Perkin Elmer is further requesting the customers to review and repeat patient samples, if PlGF control values for completed DELFIA Xpress PlGF runs with the affected product lots are not within the established acceptance range. This action has been closed-out on 04/05/2017. |
| Contact Information |
TBA |