Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-00506-1 |
Product Name/Description |
Oxoid Antimicrobial Susceptibility Testing Penicillin (P1) Discs (an in vitro diagnostic medical device (IVD))
Product Code: CT0152B
Lot Number: 1218658
Expiry: July 2015 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
5/05/2014 |
Responsible Entity |
|
Reason/Issue |
Investigations by the manufacturer Oxoid Limited, part of Thermo Fisher Scientific, have confirmed that cartridges within this batch may contain individual discs not impregnated with sufficient antibiotic. Continued use of this lot could result in false indication of resistance. |
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. |
Contact Information |
08 8238 9044 - Thermofisher Scientific |