Aug

2021

Recall – Cytometry software may produce erroneous results

Company: Beckman Coulter, Inc.
Date of Enforcement Report: 8/18/2021
Class I

PRODUCT

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 – Kaluza C Single Perpetual License C10575 – Kaluza C Single User 1-year License C10576 – Kaluza C 10 User Network License C10577 – Kaluza C 5 User Network License C10578 – Kaluza C Single Perpetual Educational License C10579 – Kaluza C Single User 1-year Educational License C10580 – Kaluza C 10 User Network Educational License C10581 – Kaluza C 5 User Network Educational License and C21166 – Kaluza C Program DVD v1.0

Recall Number: Z-2241-2021

REASON

Software anomalies that may lead to the generation of erroneous results.

RECALLING FIRM/MANUFACTURER

Beckman Coulter, Inc. on 6/23/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

1,085 (482 US & 603 OUS)

DISTRIBUTION

U.S. Nationwide and International

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