Source: FDA GUDID (open access, U.S. Federal public domain) · last seen 2026-09-01T07:02:36Z
🔍 What we found about this product
A factual report of what public registries and product databases returned for this EAN. We do not authenticate products or issue safety verdicts — we only report what we found.
Identifier checks
📋 EAN format: the GTIN-13 mod-10 checksum is consistent with the GS1 standard (format check only; does not authenticate the physical product)
📋 GS1 prefix 081 indicates the issuing office in United States / Canada (this is the country where the brand owner registered the EAN; it is not necessarily where the product was manufactured. Source: GS1 country code list)
📋 Brand entries found: no entry for BIOFIRE DIAGNOSTICS, LLC in the Wikidata brand registry (our coverage of Wikidata is partial; absence is not a finding either way)
📋 Listed in 0 of the public product catalogues we check (our catalogue coverage is partial; absence is not a finding either way)
Registry scans
📋 Recall registry scan returned 1 matching record (see recall section above for details. Sources scanned: CPSC, FDA, RAPEX, Health Canada, NHTSA)
📋 Substance database scan returned 0 matches (sources scanned: ECHA SVHC, REACH Annex XVII, EU RoHS, Stockholm POPs, CLP Annex VI. Coverage gaps exist)
📋 Banned-ingredient scan (EU Cosmetic Annex II) returned 0 matches (source: EU Reg. 1223/2009. Scanned against available label text only)
📋 Certifications listed in our databases: none found (registries scanned: EU Ecolabel, US ENERGY STAR, US EPA Safer Choice. Many legitimate products are not enrolled in these schemes)
📋 Medical device registry: listed in US FDA GUDID (entry)
Sources scanned: GS1 country prefix · Wikidata brand registry · Open Beauty / Food Facts · USDA FDC Branded Foods · Nudger GTIN dataset · EU Safety Gate (RAPEX) · US CPSC · US FDA recalls · Health Canada Recalls · NHTSA recalls · ECHA SVHC · REACH Annex XVII · EU RoHS · Stockholm POPs · CLP Annex VI · EU Cosmetic Annex II · EU Ecolabel · US ENERGY STAR · US EPA Safer Choice · US FDA GUDID · EU EUDAMED. Last refreshed: .
About this section. We aggregated what we found across 24 public registries and product databases as of . This is not an authentication, certification, or safety endorsement. Coverage gaps in our source data exist. For definitive verification, please contact the manufacturer or the relevant regulator directly.
Recall history (1)
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 — 2023-02-01 00:00:00 [US FDA - Medical Devices] (source) 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 re
Disclaimer. Substance and ingredient information is matched against public government registries (cited above) and may be incomplete or imprecise for a specific batch. This page is informational only and does not constitute medical, legal, or safety advice. For health concerns consult a qualified specialist. For confirmed product safety status refer to the manufacturer and the linked regulatory source.
Provenance
Data source: gudid_fda. See About for the full source list.