| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00975-1 |
| Product Name/Description |
BBL MGIT Mycobacteria Growth Indicator Tube
(used for the detection and recovery of mycobacteria including mycobacterium tuberculosis)
Catalogue Number: 245122
Lot Number: 3061013
Expiry date: 6 September 2014
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
BD has determined that affected BBL MGIT tubes were labelled with an incorrect barcode, such that the correct barcode prefix "43 01" was actually printed as "43 02". The manufacturer identified this error prior to supplying the product and over labelled the product with the correct barcode. The manufacturer has identified that the over labels may peel off in varying degrees which exposes the incorrect barcode. This can result in MGIT false negative results. |
| Recall Action |
Recall |
| Recall Action Instructions |
BD is requesting users to discontinue use and discard any remaining inventory of the affected product. Replacement stock will be provided by BD. The package insert recommends that users perform a visual check of all instrument negative tubes. Tubes that appear to be positive should be sub-cultured, acid-fast stained and treated as a presumptive positive. A review of previously reported results is not required if this protocol is followed. |
| Contact Information |
1800 656 100 - BD Customer Service |