| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00386-1 |
| Product Name/Description |
MV1031 Gram Crystal Violet 4L. An in vitro diagnostic medical device (IVD)
Lot Number: 1339353 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
5/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Investigations have confirmed that this batch of Gram Crystal Violet may be contaminated with an environmental Gram-negative bacillus. Continued use of this batch may result in an appearance that those cultures being stained include a Gram-negative rod, or that otherwise sterile samples may contain this organism. |
| Recall Action |
Recall |
| Recall Action Instructions |
Laboratories are requested to cease use and discard the affected lot of Gram Crystal Violet. This action has been closed-out on 03/03/2016. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |