Type of Product |
Medical Device |
TGA Recall Reference |
RC-2014-RN-01014-1 |
Product Name/Description |
Horse Blood Agar. An in vitro Diagnostic Medical Device (IVD)
Product Reference: 04059
Batch Number: EHU-302
Expiry Date: 2014-10-23
ARTG Number: 201986 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
12/11/2014 |
Responsible Entity |
|
Reason/Issue |
bioMerieux have identified the product may contain low level contamination in some plates. Contaminants were identified as (1) Bacillus cereus, (2) Hafnia alvei, and (3) Staphylococcus epidermidis. |
Recall Action |
Recall |
Recall Action Instructions |
bioMérieux requested the customers to inspect the above product prior to use and discard any plates found to be contaminated. Complimentary replacement stock has been shipped in the same quantity as originally provided.
This action was undertaken prior to approval of the recall strategy by the TGA. |
Contact Information |
07 3902 6417 - bioMerieux Australia |