CanadaWhat's being recalled
Companies: Agilent Technologies, Inc., 5301 Stevens Creek Boulevard, Santa Clara, California, United States, 95051.
How to identify it
Affected product: PD-L1 IHC 22C3 pharmDx; Lot or serial number: 12001736B; Model or catalogue number: GE006
Affected product: PD-L1 IHC 22C3 pharmDx; Lot or serial number: 12010368B; Model or catalogue number: GE006
Affected product: PD-L1 IHC 22C3 pharmDx; Lot or serial number: 11992577B; Model or catalogue number: GE006
The hazard
Agilent identified missing hyphens in the IFU for PD-L1 IHC 22C3 pharmDx (GE006), revision 02 (PD005650). Due to an inadvertent formatting change in section "9.2 tissue sections," tissue-section thickness was incorrectly listed as 45 μm instead of 4-5 μm, and slide-storage temperature was incorrectly listed as 28 °c instead of 2-8 °c. This issue is limited to the electronic IFU (eIFU) associated with the three lots.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)