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
cobas e 801 immunoassay analyzer, cobas 8000 Modular Series The device is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series. It uses electrochemiluminescent technology for signal generation and measurement.
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
These labels are deterministic app interpretations, not FDA categories.
The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function.
