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.
Reported: September 1, 2021 Initiated: July 15, 2021 #Z-2332-2021
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.
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 180 units
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Beckman Coulter Inc.. Units affected: 180 units.
Why was this product recalled? ▼
There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2332-2021.
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