Quality & complianceOfficial

Health Canada flags labelling errors in electronic instructions for Agilent PD-L1 IHC 22C3 pharmDx

🇨🇦 Health Canada · Wed 28 Oct 2026

Agilent's electronic instructions for three lots wrongly give tissue-section thickness and slide-storage temperature, after hyphens were lost in a formatting change, Health Canada reports.

Health Canada has published a Type II recall of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, a microbiology-category medical device. The notice, dated 28 October 2026, carries identification number RA-82862 and gives a recall date of 15 October 2026.

Agilent found that hyphens were missing from the instructions for use (IFU) for model GE006, revision 02 (PD005650). An inadvertent formatting change in section 9.2, on tissue sections, caused the errors.

As a result, tissue-section thickness appears as 45 μm instead of the intended 4-5 μm. Slide-storage temperature appears as 28 °c instead of 2-8 °c.

Health Canada says the problem is confined to the electronic IFU (eIFU) associated with three lots: 12001736B, 12010368B and 11992577B. The source does not describe any problem with the product itself, nor does it report any harm or complaints.

The notice asks healthcare audiences to contact the manufacturer for more information. A Type II recall is generally one where use of the product may cause temporary or medically reversible health effects, or where the risk of serious harm is considered remote.

What it means for your team

  • Laboratories using lots 12001736B, 12010368B or 11992577B should check which version of the eIFU their staff are consulting, particularly section 9.2.
  • Quality teams should note that the stated correct values are 4-5 μm section thickness and 2-8 °C slide storage, and that the faulty values arose from lost hyphens.
  • Manufacturers may take from this a reminder to check that formatting and document-conversion changes do not alter numerical ranges in labelling.
  • Anyone needing more detail on corrective steps should contact Agilent, as the notice gives no further instructions.

Official source: Health Canada ↗

Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.

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