FDAFDA · Food and drugs·Recall number Z-2332-2021
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.
Published September 1, 2021 · Recall initiated: July 15, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- Software Version 2.0 and 2.1
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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