PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine… — Class II medical device recall Z-2425-2018
Terminated recall by Dako North America Inc., reported 2018-07-18, distributed in AZ, CA, CO, CT, DC, FL, GA, IL…. To correct the kit's instructions for use as the storage time for gastric and gastroesophageal junction adenoc
| Recall number | Z-2425-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako North America Inc., Carpinteria, CA, United States |
| Recall initiated | 2018-02-02 |
| Classified | 2018-07-11 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-11-10 |
| Distributed | AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NH, NJ, NV, NY, OH, OK, PA, TX, UT, VA, WA, WI |
| Quantity | 1,051 kits |
| Lot numbers | 10126716C, 10127731A, 10127741, 10129051, 10132199 |
Product
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2425-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.