Coulter Gen-S System

• • Terminated Z-1956-2011 FDA Unclassified (pre-2012) ·initiated 31 Jan 2011

  This recall was initiated because Beckman Coulter identified a problem with some date fields that are transmitted to the Laboratory Information System (LIS). Starting Jan 1, 2011, the date fields will transmit as a blank field to the LIS if the year is greater than 2010. The following dates are affected: Run date, Control expiration date, Date of birth (For individuals born in 2011 or later), a

• • Terminated Z-0315-2008 FDA Unclassified (pre-2012) ·initiated 18 Apr 2007

  Patient Mis-identification can occur: 1)- When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- When manually entering a Patient ID, if a blank space is entered between th

• • Terminated Z-0475-06 FDA Unclassified (pre-2012) ·initiated 15 Dec 2005 ·on shared 510(k) K962988

  There is a risk of sample misidentification when processing samples in the Manual aspiration mode.

• • Terminated Z-0571-03 FDA Unclassified (pre-2012) ·initiated 10 Dec 2002 ·on shared 510(k) K962988

  Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K962988 ↗

FDA Product Code

GKL

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Coulter Albumin Reagent

  Class II

  FDA 510(k) K901268 Active Cleared 30 May 1990

• Coulter Ck (Creatine Kinase) Reagent

  Class II

  FDA 510(k) K901267 Active Cleared 23 May 1990

• Coulter Hdl - Cholesterol Reagent

  Class I

  FDA 510(k) K902174 Active Cleared 31 Jul 1990

• Coulter Total Bilirubin Reagent

  Class II

  FDA 510(k) K901266 Active Cleared 25 Apr 1990

• Coulter Linearity Control

  Class II

  FDA 510(k) K955334 Active Cleared 8 Feb 1996

• Immuno-Trol Control Cells

  Class II

  FDA 510(k) K984216 Active Cleared 16 Mar 1999

See all devices from Coulter Corp. →

• What types of hematology measurements does the Coulter Gen‑S System perform?

  The system conducts quantitative cell counting, leukocyte differential counting, and reticulocyte analysis. By integrating these functions, it delivers a comprehensive blood profile from a single sample, which streamlines workflow and reduces the need for multiple instruments in a clinical laboratory.

• Is the Coulter Gen‑S System supplied as a single unit or in multiple components?

  It is supplied as a complete, integrated analyzer by Coulter Corp. in Miami, FL. The package includes the hardware, software, and necessary accessories for operation, so laboratories receive a ready‑to‑use system without having to assemble separate modules.

• What is the regulatory classification and clearance pathway for this device?

  The Gen‑S System is classified as a Class II medical device and received FDA 510(k) clearance (K962988) as a substantially equivalent hematology counter. This clearance indicates that the device meets the safety and effectiveness standards required for in‑vitro diagnostic use in the United States.

• Can the Coulter Gen‑S System be used for point‑of‑care testing or is it limited to central labs?

  The device is intended for use in clinical laboratory settings, not for point‑of‑care environments. Its design, throughput, and integration with laboratory information systems make it suitable for centralized testing rather than bedside or bedside‑adjacent applications.

• How does the system ensure reproducible results across multiple runs?

  Automation of sample handling, standardized reagent delivery, and built‑in quality‑control algorithms allow the Gen‑S System to produce rapid and reproducible hematology results. Consistent particle counting and differential analysis reduce operator variability and support reliable longitudinal patient monitoring.