FDA Device Intelligence
Home › Selux Diagnostics, Inc. › Bulk Analyzer Reagent Pack

Bulk Analyzer Reagent Pack

Selux Diagnostics, Inc. · Model 01-10019 · UDI-DI 00850031114005

LTWLTTLON Prescription
2
510(k) clearances
10
Adverse events
39
Recalls
10
Facilities

Recalls

DateFirmReason
2026-01-05Biomerieux IncPotential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aerugin
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2022-11-09Biomerieux IncAs the temperature and time out of range was exceeded, product performances cannot be guaranteed
2016-02-24Biomerieux IncProduct insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
2016-02-24Biomerieux IncProduct insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
2016-02-24Biomerieux IncProduct insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
2016-02-24Biomerieux IncProduct insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
2016-02-24Biomerieux IncProduct insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
2016-02-24Biomerieux IncProduct insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
2016-02-24Biomerieux IncProduct insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.