| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00516-1 |
| Product Name/Description |
ThinPrep 5000 Processor with Autoloader
ARTG Number: 224862 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
An investigation of customer complaints has determined that in rare cases, it is possible for the ThinPrep 5000 Processor with Autoloader to misread the value encoded in the vial barcode label. This occurs when the barcode scanner decodes a value that meets all symbology rules and check-digit validation but is not the intended value encoded in the barcode and processes the vial using this identifier.
This potential is only present in ThinPrep 5000 Processor with Autoloader configurations and is not present in the Benchtop configuration. In an Autoloader configuration, if a misread occurs, the misread vial ID value is transferred to the slide and a slide is produced with the incorrect identifier. There is a risk of misidentification of a patient slide. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Hologic is advising users to ensure the labels are graded against the appropriate standard. The Technical Information Reference Guide has been updates to clarify the barcode quality and specification requirements.
Hologic is providing users with a software update to perform additional safety reads to improve identification of inadequate labels.
Hologic is also providing users with updated barcode scanners. This action has been closed out on 19/01/2016. |
| Contact Information |
1800 264 073 - Hologic Australia |