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Beckman Coulter Inc. recalls Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces betwe
Recalled September 1, 2021 · FDA recall Z-2332-2021 · Beckman Coulter
Hazard
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result. · FDA Class II
Units
180 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zimbabwe.
Description
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
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.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →