Nephelometer, For Clinical Use
Clinical Chemistry · 21 CFR 862.2700
Recent MDR events
258 adverse event reports on file
- BD Phoenix¿ APJul 30, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-01373
- BD Phoenix¿ APJul 27, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-01347
- BD PHOENIX¿ APJul 21, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-01343
- BD PHOENIX¿ APJul 10, 2026MalfunctionBecton, Dickinson & Co. (sparks)1119779-2026-01317
- BD PHOENIX¿ APMay 22, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00840
- BD PHOENIX¿ APMay 19, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00792
- BD PHOENIX¿ APApr 13, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00667
- BD PHOENIX¿ APApr 9, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00634
- BD PHOENIX¿ APApr 9, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00641
- BD PHOENIX¿ APApr 3, 2026MalfunctionBecton Dickinson & Co. (sparks)1119779-2026-00604
Event type breakdown
Recalls
4 recall events for this product code
- Beckman Coulter Inc.TerminatedAug 10, 2010
IMMAGE Immunochemistry Systems Buffer 1 (BUF1), Part Number: 447650
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 of IMMAGE BUF1. Some lots of BUF1 have been reported to cause high shifts in recovery of control or patient samples. Quality Control failures may result after replacing BUF1 with a different lot.
Z-2195-2010 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJan 25, 2006
BD PhoenixSpec Nephelometer, Catalog #440910.
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.
Z-0443-06 · View FDA record ↗ - Becton Dickinson & Co.TerminatedJan 24, 2006
BD PhoenixSpec Calibrator Kit, consisting of 3 tubes identified as 0.25, 1.0 and 4.0 McFarland unit calibrators, and labeled in part ***Becton, Dickinson and C
A calibrator for an in vitro diagnostic kit is not standarized correctly and may cause a calibration error when measuring microbiological cultures for turbidity.
Z-0430-06 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
BD PhoenixTM AP, Catalog Number 448010
Potential unexpected movement of robot arm
Z-0198-2018 · View FDA record ↗
Registered firms
13 firms currently registered for this product code
Strumed Solutions Private Limited
Surat Gujarat, IN
Gfs Chemicals, Inc
Powell, OH, US
Remel Cleveland, A Division Of Remel Inc.
Oakwood Village, OH, US
Beckman Coulter Laboratory Systems (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Becton, Dickinson & Co.
SPARKS, MD, US
Trek Diagnostic Systems, Ltd.
East Grinstead West Sussex, GB
Becton, Dickinson & Co.
Cockeysville, MD, US
Remel, Inc.
LENEXA, KS, US
Plexus Manufacturing Sdn .bhd.
Bayan Lepas Pulau Pinang, MY
Diamond Diagnostics Inc.
Budapest, HU
Beckman Coulter, Inc.
BREA, CA, US
Healgen Scientific Llc
Houston, TX, US
Zhejiang Orient Gene Biotech
Huzhou Zhejiang, CN
510(k) clearances
14 clearances for this product code
- Beckman Instruments, Inc.Aug 21, 1996
K962294 · IMMAGE IMMUNOCHEMISTRY SYSTEM
- Beckman Instruments, Inc.Aug 19, 1992
K922273 · ARRAY(R) 360
- Seradyn, Inc.Mar 28, 1989
K885263 · QMS(TM) - THEOPHYLLINE
- Abbott LaboratoriesApr 30, 1985
K851253 · TDX ANALYZER W/NEPHELOMETRY CAROUSEL
- Abbott LaboratoriesApr 29, 1985
K851234 · A-JUST TURBIDITY METER
- J.T. Baker Chemical Co.Jul 21, 1980
K801362 · ALBUMIN NEPHELOMETRIC ASSAY
- J.T. Baker Chemical Co.May 28, 1980
K801089 · J.T. BAKER NEPHELOMETER
- Biovation, Inc.Oct 30, 1979
K792045 · BIOVATION NEPHELOMETER