Device product
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
Z-2425-2018
Product summary
- Event
- Event 79602
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1051 kits
- Official record key
device-enforcement:Z-2425-2018
Official wording
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.
Code information: Code No SK006 Lot #'s: 10127731A, 10126716C, 10127741, 10129051 and 10132199
Distribution pattern: 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
Derived failure modes
-
Unknown
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.