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