The FDA has posted 5 enforcement recalls of for clinical use calculator/data processing module devices since 2025, none of them Class I (most serious). Most recent report: Aug 12, 2026.
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting of test outcomes.
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor.…
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may incorre…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Calculator/Data Processing Module, For Clinical Use”). Informational only — verify against the FDA before acting.