| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01149-1 |
| Product Name/Description |
Oxoid Antimicrobial Susceptibility Testing Disc for Penicillin G (P1). An in vitro diagnostic medical device (IVD)
Product Code: CT0152B
Lot Number: 167623
ARTG Number: 208273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/11/2015 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Oxoid Limited, part of Thermo Fisher Scientific, has confirmed that Oxoid Antimicrobial Susceptibility Testing Disc Penicillin G (P1), CT0152B lot 1675623 may contain a small number of discs that produce variable results. Not all of the lot is affected however our investigation identified that the size of the inhibition zone varied significantly with some discs producing larger than expected, unexpected or irregular zones of inhibition.
Continued use of this lot could result in quality control failures, delayed results or false susceptibility 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 |