| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00168-1 |
| Product Name/Description |
VITEK 2 60/XL and VITEK 2 Compact systems (In vitro diagnostic medical devices (IVD) used Bacterial identification and antibiotic sensitivity system)
Used with the following PC models:
Hewlett-Packard rp5700, Catalogue Number W0452
Hewlett-Packard rp5800 XPE, Catalogue Number 413642
Hewlett-Packard WES7, Catalogue Number 413862
Hewlett-Packard dc7800, Catalogue Number W0449
Hewlett-Packard dc7700 8-port, Catalogue Number W0447
Hewlett-Packard dc7100 8-port, Catalogue Number W0441 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Under specific conditions, VITEK 2 60/XL and VITEK 2 Compact PC Systems connected to a Laboratory Information System have the potential to link a test result to an incorrect patient record. The four conditions required to potentially cause an occurrence of this issue are:
- Patient Demographics option is enabled
- Patient demographics are not associated with the isolate
- User does not resolve Qualified isolates
- Laboratory re-uses Lab IDs (accession numbers) prior to Qualified isolates being resolved |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Biomerieux is updating the instructions for use (IFU), addendum to the software user manual, to include appropriate instructions for resolution of Qualified isolates as a short term action. Biomerieux is implementing a software solution to reduce the likelihood of occurrence of this issue in the next software update, version 7.01 targeted for launch in November 2013. |
| Contact Information |
1800 333 421 - BioMerieux Australia Technical Assistance |