# FDA recall Z-2425-2018

> **Dako North America Inc.** · Class II · device recall initiated 2018-02-02.

## 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.

## Distribution

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, and WI

## Key facts

- **Recall number:** Z-2425-2018
- **Recalling firm:** Dako North America Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-02
- **Report date:** 2018-07-18
- **Termination date:** 2020-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carpinteria, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2425-2018

## Citation

> AI Analytics. FDA recall Z-2425-2018. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/Z-2425-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*