Recall Z-2425-2018— Dako North America Inc.
Class II · Terminated
Class II FDA medical device recall by Dako North America Inc., initiated 2018-02-02, terminated 2020-11-10. FDA's recall record names no specific 510(k) clearance for this event. Product: PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.. Reason: 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..
- Recalling firm
- Dako North America Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-02
- Terminated
- 2020-11-10
- Firm location
- Carpinteria, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.