Normand Remisol Advance Data Manager recall
Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information…
Why was Normand Remisol Advance Data Manager 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Version 2.0 and 2.1
- Product
- Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 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.
- Recall date
- September 1, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)