Recall Z-1831-2021 ยท JQP Calculator/Data Processing Module, For Clinical Use
Normand-Info S.A.S.U.
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.
| Date | Mar 22, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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 Hamp |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.