FDA-Device2021-09-01Class II
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.
Beckman Coulter Inc.
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.
Sold states
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.
Affected count
180 units
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2332-2021Don't want to check this manually?
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