FDAFebruary 2, 2018device
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months.
What to do
FDA enforcement status: Terminated
Brands named
dako north americadakodako north
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAPhilips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.2026-06-05
- FDAPhilips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A2026-05-26
- FDAPhilips Avalon Fetal Monitor, FM 30 Part numberM2703A2026-05-26
- CPSCPetzl America Recalls SIMBA and SWAN EASYFIT Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
- CPSCPetzl America Recalls ASTRO BOD FAST, ASTRO SIT FAST and CANYON GUIDE Harnesses Due to Risk of Serious Injury or Death from Fall Hazard2026-05-14
- FDADigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.2026-05-01
- CPSCAcer America Corporation Recalls Two-Wheeled Folding Electric Due to Risk of Injury from Fall Hazard2026-04-30
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