openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options.
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.
These labels are deterministic app interpretations, not FDA categories.
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
