| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00271-1 |
| Product Name/Description |
FilmArray Blood Culture Identification (BCID) Panel when used with BD BACTEC Blood Culture Bottles. An in vitro diagnostic medical device (IVD)
All lots of FilmArray Blood Culture Identification (BCID) Panel are impacted when used with specific BD media types
Multiple BD BACTEC Blood Culture Bottles with expiry dates after September 30 2018 may impact results
ARTG Number: 223979
(Biomerieux Australia - Bacterial infectious disease IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
bioMérieux Australia has been advised that the manufacturer, BioFire Diagnostics, has identified an increased risk of false positive Proteus results when the FilmArray Blood Culture Identification (BCID) Panel is used with BD BACTEC Blood Culture Bottles with expiration dates of September 30, 2018 and October 31, 2018. It is unknown if subsequent lots of media will also be subject to this risk; however, BioFire and BD are continuing to investigate the issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
bioMérieux is advising customers to verify positive results for Proteus by confirming with another method where BD BACTEC Blood Culture Bottles with expirations on 30/09/2018 and 31/10/2018 have been used due to the BCID Panel detecting nucleic acid from non-viable Proteus.
This action has been closed out on 13/02/2019 |
| Contact Information |
02 8852 4700 - bioMerieux Australia |