Type of Product |
Medical Device |
TGA Recall Reference |
RC-2024-RN-00090-1 |
Product Name/Description |
CooperSurgical SupraSperm 100 Gradient Medium
Part Number: 10970060A
Lot Number: 230331-013796
Expiry: 30/01/2024
ARTG 200537 (Origio Australasia Pty Ltd - In vitro fertilization culture medium) |
Recall Action Level |
Retail |
Recall Action Classification |
Class III |
Recall Action Commencement Date |
9/02/2024 |
Responsible Entity |
|
Reason/Issue |
The manufacturer has become aware of an expiry date mislabelling. It was internally identified that the expiry date on the certificate of analysis (30-Jan-2024) did not match the date indicated on the label (21-Jun-2024). Through investigation, it was determined that the expiry dates on the labels for both the bottles and boxes in this lot of SupraSperm 100 medium were incorrect. The actual expiry date was 30-Jan-2024.
This recall action was undertaken prior to TGA notification. |
Recall Action |
Recall |
Recall Action Instructions |
Customers were asked to inspect their inventory, identify, and quarantine SupraSperm 100 Sperm Gradient Medium Part Number: 10970060A, Lot number 230331-013796. For opened bottles in use, customers were told to dispose of the product as they would any expired product. |
Contact Information |
02 9191 1528 - Customer service |