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¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
These labels are deterministic app interpretations, not FDA categories.
An error was found within the Hungarian translations of the cobas¿ EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas¿ cfDNA Sample Preparation Kit Instructions for Use (M/N 07573758001-01HU, Doc. Rev. 1.0, Dated 05/2015).
