Home › TREK DIAGNOSTIC SYSTEMS LIMITED › SENSITITRE NEPHELOMETER

SENSITITRE NEPHELOMETER

TREK DIAGNOSTIC SYSTEMS LIMITED · Model V3011 · UDI-DI 05032384474516

JQX Prescription

510(k) clearances

258

Adverse events

Recalls

Facilities

Description

The Sensititre™ Nephelometer is used for standardizing the inoculum density of a bacterial suspension. Light from an ultrabright light emitting diode (LED) is scattered by bacteria in suspension and detected by a photodiode. The quantity of scattered light is compared with a reference value obtained by calibrating the Nephelometer with a 0.5 McFarland turbidity standard.

Recalls

Date	Firm	Reason
2017-06-01	Becton Dickinson & Co.	Potential unexpected movement of robot arm
2010-05-21	Beckman Coulter Inc.	Beckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots
2006-01-17	Becton Dickinson & Co.	A operator's manual for a diagnostic test kit is incorrect and may cause inaccurate results for bacterial identification and antibiotic susceptibility in patient samples.
2005-12-01	Becton Dickinson & Co.	A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.

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 key Read 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.