OFFICIAL-SOURCE RECALL · AUSTRALIA
Fertilisation Medium FEM-50 Recall: Classification Class III Reason for the Action The
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Fertilisation Medium FEM-50
- Manufacturer
- See official notice
- Lot number
- J000007889
- Batch number
- J000007889
- Date code
- dates, Date
- Expiration date
- dates, Date
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
Classification Class III Reason for the Action The endotoxin testing method has changed due to the end of life of the testing kits used by Genea Biomedx for quantifying endotoxin levels. The Instructions for Use (IFU) was not updated to remove the mention of the previous LAL test method. Specification remains the same, no other product change, no impact on product safety or performance. Instructions for Customers/Users The updated hardcopy IFU with Endotoxin test method wording update will be shared by Genea Biomedx. Customers are to: - Replace the previous revision supplied. Action Commencement Date 27/07/2026 Responsible Entity Genea Biomedx Pty Ltd
Hazard
Classification Class III Reason for the Action The endotoxin testing method has changed due to the end of life of the testing kits used by Genea Biomedx for quantifying endotoxin levels. The Instructions for Use (IFU) was not updated to remove the mention of the previous LAL test method. Specification remains the same, no other product change, no impact on product safety or performance. Instructions for Customers/Users The updated hardcopy IFU with Endotoxin test method wording update will be shared by Genea Biomedx. Customers are to: - Replace the previous revision supplied. Action Commencement Date 27/07/2026 Responsible Entity Genea Biomedx Pty Ltd
Official recall notice
Fertilisation Medium FEM-50
Agency: Therapeutic Goods Administration
Official publication date: April 29, 2026
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