| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00869-1 |
| Product Name/Description |
Gram Crystal Violet stain MV1031
Lot Numbers: 1342111, 1343824, 1345711, 1346829 and 1350380
ARTG Number: 235291 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
8/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Investigations have confirmed that this batch may be contaminated with an environmental Gram-negative bacillus. Continued use of this batch may result in the appearance that those cultures being stained include a Gram-negative rod, or that otherwise sterile samples may contain Gram-negative rods. |
| 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 04/03/2016. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |