Recall – Erroneous patient results due to software error in LIS

Company: Beckman Coulter Inc.
Date of Enforcement Report: 9/1/2021
Class II

PRODUCT

Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

Recall Number: Z-2332-2021

REASON

There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.

RECALLING FIRM/MANUFACTURER

Beckman Coulter Inc. on 7/15/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

180 units

DISTRIBUTION

U.S. Nationwide and International

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