| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01190-1 |
| Product Name/Description |
Oxoid AST Disc - Ceftazidime CAZ10. An in vitro diagnostic medical device (IVD)
Product Code: CT1629B
Lot Numbers: 1883326, 1849729, 1814258, 1786239, 1752930, 1728103, 1683346, 1646438, 1611709, 1571939, 1562018, and 1558378
ARTG Number: 208273 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
An internal technical investigation by Oxoid, part of Thermo Fisher Scientific, has confirmed that the concentration of antibiotic in ThermoScientific Oxoid CAZ10 Ceftazidime, CT1629B (specific lots) may decrease over shelf life if not stored frozen. Specifically, antibiotic degradation has been identified in product stored at 8°C between 2 and 3 years of shelf life. Continued use of lots older than 24 months if stored at 2-8°C, could result in false resistance reporting for ceftazimide. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Users are to inspect stocks and remove from further use all units from the nominated batch number, then complete the supplied Facsimile Reply Form a for a credit note to be issued.
2. Complete the supplied facsimile Reply Form even if there is no remaining stock subject to recall, so as to reconcile this process.
This action has been closed out on 6/09/2018. |
| Contact Information |
08 8238 9044 - Thermo Fisher |