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Calculator/Data Processing Module, For Clinical Use

FDA product code JQP · Class 1 · Clinical Chemistry

945
Registered devices
2,167
Adverse events
220
Recalls
78
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2026-06-16Copan WASPDue to a software issue within the WebApp that potentially prevents the user to overwrite the results.
2026-04-29Beckman Coulter Biomedical GmbHDue 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
2025-09-23Becton Dickinson & Co.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product se
2025-04-08Beckman Coulter Inc.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
2025-02-05Medical Information Technology, Inc.Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti
2024-10-31Becton Dickinson & Co.BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Unti
2024-09-12Becton Dickinson & Co.Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectl

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