Health product recall

PD-L1 IHC 22C3 pharmDx

Last updated

Summary

Product
PD-L1 IHC 22C3 pharmDx
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected product

Lot or serial number

Model or catalogue number

PD-L1 IHC 22C3 pharmDx

12001736B

GE006

PD-L1 IHC 22C3 pharmDx

12010368B

GE006

PD-L1 IHC 22C3 pharmDx

11992577B

GE006

Issue

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.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Microbiology
Companies
Agilent Technologies, Inc.
5301 Stevens Creek Boulevard, Santa Clara, California, United States, 95051
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82862

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