24

Jul

2019

Recall – Cytometry software compatibility issue with Microsoft updates

recall, softwarechange

0

Company: Beckman Coulter Inc.
Date of Enforcement Report: 7/24/2019
Class II

PRODUCT

Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software

Recall Number: Z-1982-2019

REASON

Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.

RECALLING FIRM/MANUFACTURER

Beckman Coulter Inc. on 9/17/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
41 units

DISTRIBUTION

US Nationwide and International

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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Instructor: Brian Pate

Next public offering: June 24-26, 2025 (Boston, MA)

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Americas: 11-13 February 2025
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See our post titled: 1st Quarter 2025 Agile Compliant Courses Scheduled

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2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD