OFFICIAL-SOURCE RECALL · AUSTRALIA
Panocell 16. An in vitro diagnostic medical device (IVD) Recall: Classification Class III Reason for the
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Panocell 16. An in vitro diagnostic medical device (IVD)
- Manufacturer
- See official notice
- Lot number
- numbers, 17453
- Batch number
- numbers
- Date code
- dates, 03/07/2026
- Expiration date
- dates, 03/07/2026
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 Antibody identification testing performed with Donor B11752 (cell 11 of lot 17453/17453Z) may show positive reactions in the presence of Anti-P1, while the negative antigen from the master list would suggest a negative reaction would be expected. The remaining donor cells included in this lot of Panocell-16 provide additional P1 antigen positive and P1 antigen negative cells to support antibody identification. Instructions for Customers/Users Customers should assess any potential impact in accordance with procedures. Facilities can continue to use these products as intended. A revised master list 17453A has been provided for user convenience, and an additional copy can be found on Werfen's Customer Centre. For customers using the Panel ID exclusion functionality within ImmuLINK, no further actions are required. Previous antibody identification testing involving donor B11752 (cell 11) test results may be considered valid provided that: Panocell-16 • The vial(s) of Panocell-16 used in testing were not discoloured. • The quality controls described in the Quality Control section of the Instructions for Use IFU)/package insert were performe
Hazard
Classification Class III Reason for the Action Antibody identification testing performed with Donor B11752 (cell 11 of lot 17453/17453Z) may show positive reactions in the presence of Anti-P1, while the negative antigen from the master list would suggest a negative reaction would be expected. The remaining donor cells included in this lot of Panocell-16 provide additional P1 antigen positive and P1 antigen negative cells to support antibody identification. Instructions for Customers/Users Customers should assess any potential impact in accordance with procedures. Facilities can continue to use these products as intended. A revised master list 17453A has been provided for user convenience, and an additional copy can be found on Werfen's Customer Centre. For customers using the Panel ID exclusion functionality within ImmuLINK, no further actions are required. Previous antibody identification testing involving donor B11752 (cell 11) test results may be considered valid provided that: Panocell-16 • The vial(s) of Panocell-16 used in testing were not discoloured. • The quality controls described in the Quality Control section of the Instructions for Use IFU)/package insert were performe
Official recall notice
Panocell 16. An in vitro diagnostic medical device (IVD)
Agency: Therapeutic Goods Administration
Official publication date: July 3, 2026
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