Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Cytomics FC 500 MPL Flow Cytometry System with MXP Software, Software Version 2.1, Automated differential cell counter, Part Number: 626554, Beckman Coulter, Fullerton, CA 92834

FDA Recall Z-0958-2008 · Posted 2008-04-30

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2007-06-29
Date Terminated2012-12-13
Product Quantity516 units in the US; 73 units in Canada

Reason for Recall

Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.

Firm Action

Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution- USA and country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071681CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554Beckman Coulter, Inc. · 2007-10-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑