| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01257-1 |
| Product Name/Description |
96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System)
Siemens Material Number: 10283255
Lot Number: 143449
ARTG Number: 175890
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
Siemens Healthcare Diagnostics is providing this communication to customers regarding a defect observed in the Deep Well Plate used on the VERSANT kPCR Sample Preparation and Tissue Preparation Systems. Multiple plates in lot 143449 have been observed to have extraneous plastic in the interior of the well at position F7 of the plate. If present, this extraneous plastic may cause a jam of the 1 mL pipet tip during dispense of reagent. The jamming of the pipet tip may result in a failure of the run. This failure will prevent the reporting of any patient results from that run and the samples must be repeated. |
| Recall Action |
Recall |
| Recall Action Instructions |
Siemens is advising users to inspect stock and to discontinue use and discard any of the affected lot.
Siemens is advising users that the review of previous patient data is at the discretion of the Laboratory Director. This action has been closed-out on 17/05/2017. |
| Contact Information |
1800 008 453 - Bio-Strategy Technical Support Centre |