Recall Z-2332-2021— Beckman Coulter Inc.

Name: FDA recall Z-2332-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-15

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-07-15, terminated 2024-06-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-07-15
Terminated: 2024-06-04
Firm location: Brea, CA, United States

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.