| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01097-1 |
| Product Name/Description |
Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin. An in vitro diagnostic medical device (IVD)
Product Code: FOX30 CT0119B
Lot Numbers: 1689092 & 1689093093
ARTG Number: 208273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Oxoid Limited, part of Thermo Fisher Scientific, has confirmed that certain lots of Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin may contain discs that have insufficient concentration of antibiotic. It has been identified that the low concentration may impact on the performance of the disc against Escherichia coli and Neisseria gonorrhoeae quality control organisms resulting in lower than expected zones of inhibition.
Performance with the Staphylococcus aureus QC organism is currently within specification.
Continued use of this lot could result in quality control failures, delayed results or incorrect results reporting. |
| Recall Action |
Recall |
| Recall Action Instructions |
End users are requested to inspect their stock for affected units. Affected units are to be removed from further use. The requirement for the review of patient results should be determined by the laboratory director. This action has been closed-out on 22/08/2016. |
| Contact Information |
08 8238 9044 - Thermo Fisher Scientific |