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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 Biomerieux Australia Pty Ltd
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