Agilent PD-L1 IHC 22C3 pharmDx Recalled Over IFU Labelling Error: Health Canada

Health Canada has published a Type II health product recall for the PD-L1 IHC 22C3 pharmDx (model GE006) from Agilent Technologies, Inc. The notice, posted on 2026-10-28 under identification number RA-82862, covers three lots and concerns a labelling error in the electronic instructions for use (eIFU), not a fault in the test kit itself. The recall date listed by the agency is 2026-10-15.

This 2026 recall is aimed at healthcare audiences, such as laboratories and clinical staff who use the product, rather than the general public. The issue falls under the Medical devices – Labelling and packaging category and is filed under Microbiology.

Products Affected by This Recall

The recall involves the PD-L1 IHC 22C3 pharmDx, catalogue number GE006, in three specific lots. The eIFU in question is revision 02 (PD005650).

• Product: PD-L1 IHC 22C3 pharmDx
• Model or catalogue number: GE006
• Lot 1: 12001736B
• Lot 2: 12010368B
• Lot 3: 11992577B
• Recall class: Type II
• Identification number: RA-82862

What Triggered the Recall

Agilent identified that hyphens were missing in the instructions for use. The company traced the problem to an inadvertent formatting change in section 9.2, titled tissue sections.

As a result of that change, two values in the electronic document were printed incorrectly. Tissue-section thickness was listed as 45 μm, when the correct value is 4-5 μm. Slide-storage temperature was listed as 28 °C, when the correct range is 2-8 °C.

In both cases the missing hyphen turned a range into a single, very different number. A reader skimming the section could easily take 45 μm to be a real specification, even though it is far outside the intended thickness.

Who Should Be Concerned

The notice is addressed to the healthcare audience. Laboratories and staff who prepare tissue sections and store slides using the GE006 kit are the people most likely to rely on section 9.2 of the instructions.

Health Canada states that the issue is limited to the eIFU associated with the three lots listed above. The source does not list any other products, lots or catalogue numbers as affected, and it does not describe any problem with the kit components themselves.

The notice does not give the number of units affected or the provinces where the product was distributed, so those details are not available from the source.

Steps Consumers Should Take

The only action Health Canada lists is for readers to contact the manufacturer if they need additional information. No return, replacement or refund process is described in the notice.

Laboratories that hold any of the three lots may wish to check the tissue-section thickness and slide-storage temperature values against the corrected figures of 4-5 μm and 2-8 °C. They should also confirm which version of the eIFU their staff are using, so the incorrect values are not followed in practice.

Agilent Technologies, Inc. is based at 5301 Stevens Creek Boulevard, Santa Clara, California, United States, 95051. Health Canada’s notice does not list a telephone number or email address, so users should contact the company through its usual customer channels.

Regulatory Response

Health Canada classified the action as a Type II recall. The notice appears on the Government of Canada recalls and safety alerts site, published by Health Canada’s Medical devices program.

The agency summarised the issue as missing hyphens in the IFU for PD-L1 IHC 22C3 pharmDx (GE006), revision 02, which caused the tissue thickness and storage temperature to be misstated. It stressed that the problem is confined to the electronic IFU tied to the three lots.

Anyone who wants to be alerted to future notices can subscribe to updates on the Government of Canada recalls site. Health or safety concerns can also be reported through the Health Canada reporting service.