Recall Z-2425-2018 ยท PLS Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1
Dako North America Inc.
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
| Date | Feb 2, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | On February 2, 2018 the firm sent letters to the consignees with the following instructions; Description of the issue: The Field Correction has been initiated to correct the kit's Instructions for Use (I FU) as the storage time for Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma cut sections will be changed from six months to five months. This means that section 8.2: Cut Section Storage Recommendation will be changed to the following: 'To preserve antigenicity, tissue sections, once mounted on slides, should be held in the dark at 2-8 C (preferred), or at room temperature up to 25 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.