| Class 2 Device Recall Normand Remisol Advance Data Manager | |
Date Initiated by Firm | March 22, 2021 |
Create Date | June 08, 2021 |
Recall Status1 |
Terminated 3 on December 30, 2022 |
Recall Number | Z-1831-2021 |
Recall Event ID |
87750 |
Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
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Product | Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments. |
Code Information |
Catalog Numbers: B08688; B22517; B35058; B74811; B92487 UDI: None Lot Numbers: All Lots |
Recalling Firm/ Manufacturer |
Normand-Info S.A.S.U. 7 rue Frederic Degeorge Arras CEDEX France
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Manufacturer Reason for Recall | Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results. |
FDA Determined Cause 2 | Labeling design |
Action | On 03/25/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification letter via postal mail or email to customers informing them that Instructions For Use for software versions 1.5 to 1.9 did not provide sufficient instructions regarding the proper programming and testing of rules. Therefore, rules written by users that were not validated or incorrectly validated may lead to erroneous results. In a worst-case scenario, unvalidated or incorrectly validated rules may lead to the generation of erroneous test results that may be reported out of the laboratory.
For customers using versions 1.5, 1.6, 1.7, 1.8 or 1.9 are instructed:
1. Validate the rules that were unvalidated or incorrectly validated,
according to laboratory procedures
2. All rules set up in the future must be validated, according to laboratory
procedures
The Recalling Firm strongly encourages the use of the testing instructions provided with this notification, "REMISOL Avanced v1.5 through v1.9 Rule Validation Procedure".
The Recalling Firm is currently updating the Instructions For Use for the affected versions and is targeting May 2021 for availability.
Customer are also instructed to:
-Share this information with their laboratory staff and to retain this information as part of their laboratory Quality System documentation.
-If customers are a centralized license holder, they are asked to provide the other affected laboratories of their organization or association with a copy of the notification letter.
-Within 10 days of receiving this customer notification, customers are asked to communicate with the Recalling Firm either: 1) Electronically, if they received this communication via email, or 2) Manually, complete and return the enclosed Response Form.
For further questions, contact the Recalling Firm via
-Website http://www.beckmancoulter.com or
-By phone - contact their local Beckman Coulter representative. |
Quantity in Commerce | 8,402 units with the affected software |
Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, South Carolina, Texas, West Virginia and Wyoming. The countries of Australia, Austria, Belgium, Brunei, Canada, China, Colombia, Congo, Czech Republic, Denmark, Ethiopia, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Lithuania, Malaysia, Mayotte, Morocco, Netherlands, Netherlands Antillean, New Zealand, Norway, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, UAE, UK, and Zimbabwe. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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