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SoftTrack
SCC SOFT COMPUTER · Model 4.1.17.243 · UDI-DI 00810055819683
10
510(k) clearances
2,167
Adverse events (5 deaths)
220
Recalls
117
Facilities
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 incorrect reporting |
| 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 service credentials ar |
| 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 set to 01/01/1900 or |
| 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. Until these product serv |
| 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. Until these product serv |
| 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. Until these product serv |
| 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. Until these product serv |
| 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 incorrectly display breakpoint |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.