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.
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
These labels are deterministic app interpretations, not FDA categories.
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Code information
Part Number: RFIT-ASY-0147 UDI: 0815381020338 Pouch Lot Number: 1766022
Distribution pattern
U.S. Nationwide distribution in the states of FL and GA.
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
These labels are deterministic app interpretations, not FDA categories.
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Code information
Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622
Distribution pattern
U.S. Nationwide distribution in the states of FL and GA.
device · product 3 of 3
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
These labels are deterministic app interpretations, not FDA categories.
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Code information
Part Number: RFIT-ASY-0116 UDI: 00815381020109 Pouch Lot Number: 1674322
Distribution pattern
U.S. Nationwide distribution in the states of FL and GA.
