Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces betwe
Summary
The FDA issued a Class II for Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is by Beckman Coulter Inc.. 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..
Details
Source
Device Recall
External ID
Z-2332-2021
Action Date
2021-09-01
Status
Terminated
Category
device
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.
Lot/Code Info: Software Version 2.0 and 2.1
Quantity Affected: 180 units
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-15
Company
Brea, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Inc. have FDA actions?
Beckman Coulter Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2332-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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