FDA Device Intelligence
Home › Device types › LIE

Reagent/Device, Inoculum Calibration

FDA product code LIE · Class 2 · Microbiology

4
Registered devices
1
Adverse events
2
Recalls
7
510(k) clearances

Devices with this code

BD BBL™ Prompt™ Inoculation System — BECTON, DICKINSON AND COMPANYTHE SENSITITRE AIM — REMEL, INC.MicroScan PROMPT — Beckman Coulter, Inc.Sensititre AIM™ — TREK DIAGNOSTIC SYSTEMS LIMITED

Recent recalls

DateFirmReason
2019-12-13Beckman Coulter Inc.Due to customer reports it has been determined that the inoculation system contains the incorrect prompt wands. Use of the incorrect wands could result in fals
2006-09-27Dade Behring, Inc.Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.

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
Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.