PD-L1 IHC 22C3 pharmDx is a companion diagnostic used recall
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Why was PD-L1 IHC 22C3 pharmDx is a companion diagnostic used recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Code No SK006 Lot #'s: 10127731A, 10126716C, 10127741, 10129051 and 10132199
- Product
- PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
- Recalling firm
- Dako North America Inc.
- Quantity
- 1051 kits
- 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
- Recall date
- July 18, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)