Official recall record
PD-L1 IHC 22C3 pharmDx
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2026-10-28
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-11-07.
Record last checked against the registry on 2026-11-07.
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