510(k) K060256 ยท CFR Hexokinase, Glucose
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 27, 2006 |
| Received | Feb 1, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060256
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2023 | Beckman Coulter, Inc. Access Immunoassay Systems
(1) Access 2 Immunoassay Analyzer
(81600N);
(2) Access 2 Immunoassay Analyzer, Refurbished (386220);
(3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and
(4) Acces Open, Classified |
JJE | None listed |
| Nov 6, 2017 | Beckman Coulter Inc. UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638.
In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentratio Terminated |
JJE | None listed |
| Jul 22, 2016 | Beckman Coulter Inc. UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems
The affected part is Part number 70300. Part number 970300 is used to transfer No Foam Solution from th Terminated |
JJE | None listed |
| Nov 6, 2014 | Beckman Coulter Inc. UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB.
Product Usage:
The DxI 600i systems are in vitro diagnostic device used for the quantita Terminated |
JJE | None listed |
| Apr 1, 2013 | Beckman Coulter Inc. UniCel DxC 600i Synchron Access Clinical System; P/N 107405S
Product Usage: The Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative or qualitative Terminated |
JJE | None listed |
| Dec 22, 2012 | Beckman Coulter Inc. Access Immunoassay System,
Access 2 Immunoassay System,
Synchron LXi 725 Clinical
System, UniCel DxC 600i
Synchron Access Clinical System
Part Numbers: Access 81600;
Access 2 81600N, 386220, A69186 Terminated |
JJE | None listed |
| Oct 24, 2012 | Beckman Coulter Inc. UniCel DxC 600/800 with
Software v5.0.11, Part Number B12218.
The UniCel DxC Synchron Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro d Terminated |
JJE | None listed |
| Oct 12, 2012 | Beckman Coulter Inc. Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i Synchron Access Clinical Systems. Part Number A45853.
Product Usage: The UniCel DxC Synch Terminated |
JJE | None listed |
| Apr 6, 2012 | Beckman Coulter Inc. Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems.
Part Number: A54378, UniCel DxC 600i APF,
Part Number: A54379, UniCel DxC 600i AAF.
The Access Im Terminated |
JJE | None listed |
| Jul 11, 2011 | Beckman Coulter Inc. UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems
The Unicel DxC Integrated Workstation takes samples loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquot Terminated |
LIG | None listed |
| Jun 23, 2011 | Beckman Coulter Inc. Tubing Assembly #142, V2, V12 Mixer/Wash a component of
the DxC instruments.
Tube, Assembly, #142 V2, V12 Mixer/Wash delivers appropriate amount of wash concentrate on the UniCel DxC SYNCHRON Clinica Terminated |
JJE | None listed |
| Apr 13, 2011 | Beckman Coulter Inc. UniCel DxC Clinical Systems with Serial Number less than 3412 Including: UniCel DxC 600 Part #: A10405,
UniCel DxC 600 PRO Part #: A11810,
UniCel DxC 600i Part #: A27318,
UniCel DxC 660i Part #: A648 Terminated |
JJE | None listed |
| Apr 12, 2011 | Beckman Coulter Inc. UniCel DxC 600i Access Immunoassay Systems, Part Number A25656.
An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration Terminated |
JJE | None listed |
| Mar 9, 2011 | Beckman Coulter Inc. GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640;
SYNCHRON and UniCel Systems and Part Numbers:
Synchron LX20, Part Number: 466200,
Terminated |
CEM | None listed |
| Dec 13, 2010 | Beckman Coulter Inc. Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N;
Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Ac Terminated |
JJE | None listed |
| Sep 30, 2010 | Beckman Coulter Inc. UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software
version: 4.9.01
The UniCel Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry Terminated |
JJE | None listed |
| Sep 20, 2010 | Beckman Coulter Inc. Closed Tube Aliquotter (CTA) for UniCel
DxC 600i, Part Number: A25637, Domestic; A25633, International
The UniCel Synchron Clinical Systems are fully automated, computer controlled clinical chemistry Terminated |
JJE | None listed |
| Sep 9, 2010 | Beckman Coulter Inc. GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel D Terminated |
CGA | None listed |
| Mar 4, 2010 | Beckman Coulter Inc. Beckman Coulter UniCel DxC Synchron Clinical System ISE Flow Cell.
PN Numbers: A10405 (UniCel DxC 600); A11810 (UniCel DxC 600 PRO); A27318 (UniCel DxC 600i); A11816 (UniCel DxC 800); A11812 (UniCel D Terminated |
JJE | None listed |
| Mar 2, 2010 | Beckman Coulter Inc. Access Peristaltic Pump component of: UniCel DxI 800 Access Immunoassay Systems, UniCel DxI 600 Access Immunoassay Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems.
Intended to be used with Terminated |
JJE | None listed |
| Feb 25, 2010 | Beckman Coulter Inc. UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1.
In vitro diagnostic device us Terminated |
JJE | None listed |
| Sep 21, 2008 | Beckman Coulter Inc Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System Terminated |
CFR | None listed |
| Aug 20, 2008 | Beckman Coulter Inc Access Power Supply Assembly Sled
Part Number: A48196/6845C; Component of: Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System, and UniCel DxC 600i System, for in vitro diagnostic use. Terminated |
JJE | None listed |
| May 24, 2008 | Beckman Coulter Inc UniCel DxC 600i, Part Numbers: A25638, A25639, Beckman Coulter, Inc. Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.