Dako PD-L1 IHC 22C3 pharmDx Recall for Storage Time Correction
Dako North America Inc. is recalling 1,051 PD-L1 IHC 22C3 pharmDx kits to correct instructions for use regarding storage time for specific tissue sections.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score when the issue is a labeling or instruction correction rather than a direct contamination or structural defect causing immediate harm.
Plain-English summary
Dako North America Inc. is recalling 1,051 kits of PD-L1 IHC 22C3 pharmDx. This companion diagnostic is used to determine PD-L1 levels to help determine patient treatment options. The recall involves specific lots: 10127731A, 10126716C, 10127741, 10129051, and 10132199, under Code No SK006.
The reason for the recall is to correct the kit's instructions for use. Specifically, the stated storage time for gastric and gastroesophageal junction adenocarcinoma cut sections will be changed from six months to five months. This is a Class II recall, indicating that use of or exposure to the product might cause temporary or medically reversible adverse health consequences.
The affected products were distributed in Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Texas, Utah, Virginia, Washington, and Wisconsin. Users should check their inventory for the affected lot numbers and follow the manufacturer's instructions for the corrected storage time.
The recalled product
- Product
- PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
- Manufacturer
- Dako North America Inc.
- Hazard
- Affected units
- 1,051
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Code No SK006 Lot #'s: 10127731A
- 10126716C
- 10127741
- 10129051 and 10132199
Distribution
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