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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 Thermo Fisher Scientific Australia & New Zealand
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