Reported Sep 1, 2021 · Terminated
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Normand Remisol Advance Data Manager
- REFC69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments
- Lot codes and dates
- Software Version 2.0 and 2.1
- Amount recalled
- 180 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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