| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00714-1 |
| Product Name/Description |
Panthera-Puncher 9, An in vitro diagnostic medical device (IVD)
Catalogue Number: 2081-0010
Serial Numbers: 20810043, 20810139 and 20810145
ARTG Number: 186748 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
3/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Wallac Oy, a subsidiary of PerkinElmer, has become aware that extended exposure to the ioniser pins of the Panthera-Puncher 9 can decrease the reaction signal level of assays using antibody coated microtiter plates (such as immunoassays). Wallac Oy's investigation has shown that uncoated plates are not affected by the phenomenon (such as enzymatic assays). The phenomenon has been determined to be localised to those wells that are located beneath or adjacent to the ioniser pins when the Panthera-Puncher 9 is idle or in sleep mode. The software allows the ioniser to remain active when the puncher is idle or has gone into sleep mode. The impact on health is dependant on the assay and the associated disorder the assay screens for in the dried blood spot sample. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
PerkinElmer is advising end users to remove plates from the Panthera-Puncher 9 when not actively punching and processing samples. If plates must reside in the device the plate track hatch should be opened to disrupt power to the ioniser. A PerkinElmer Representative will contact customers to arrange for inspection. Additionally, a software update is under development that will automatically switch off the ioniser when the device is in idle. This action has been closed on 29/01/2016. |
| Contact Information |
03 9212 8516 - PerkinElmer |