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Calculator/Data Processing Module, For Clinical Use
FDA product code JQP · Class 1 · Clinical Chemistry
975
Registered devices
2,190
Adverse events
220
Recalls
78
510(k) clearances
Devices with this code
cobas p 701 Post-Analytical Unit — Roche Diagnostics GmbHSoftPathDx — SCC SOFT COMPUTERSoftTotalQC — SCC SOFT COMPUTERSoftBiochemistry — SCC SOFT COMPUTERGE — BIONIME CORPORATIONREMISOL Advance — Beckman Coulter, Inc.SoftBiobank — SCC SOFT COMPUTERClinisys Laboratory Solutions — CliniSys, IncAutoMate 800 Sample Processor — Beckman Coulter, Inc.ACCELERATOR — ABBOTT LABORATORIESSoftBiochemistry — SCC SOFT COMPUTERSoftTrack — SCC SOFT COMPUTERSoftGenomics — SCC SOFT COMPUTERSoftHLA — SCC SOFT COMPUTERSoftLab — SCC SOFT COMPUTERKaluza C — Beckman Coulter, Inc.SoftPathDx — SCC SOFT COMPUTERSoftIWS — SCC SOFT COMPUTERClinisys Atlas — CliniSys, IncSoftFlowcytometry — SCC SOFT COMPUTERSoftCytogenetics — SCC SOFT COMPUTERClinisys SQ Lab — CliniSys, IncSoftMolecular — SCC SOFT COMPUTERSoftMolecular — SCC SOFT COMPUTER
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-16 | Copan WASP | Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. |
| 2026-04-29 | Beckman Coulter Biomedical GmbH | 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 |
| 2025-09-23 | Becton 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 |
| 2025-04-08 | Beckman 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 |
| 2025-02-05 | Medical 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. |
| 2024-10-31 | Becton 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 |
| 2024-10-31 | Becton 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 |
| 2024-10-31 | Becton 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 |
| 2024-10-31 | Becton 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 |
| 2024-09-12 | Becton 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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