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POC Controller
BYG INFORMATIQUE · Model 1 · UDI-DI 03770035155064
10
510(k) clearances
2,190
Adverse events (5 deaths)
220
Recalls
116
Facilities
Description
POC Controller is a software middleware intended for use by laboratory professionals in single-site and multi-site clinical laboratories performing in vitro diagnostic point-of-care testing. The software is designed to automate the acquisition, consolidation, supervision, and transfer of data between POCT instruments (IVD) and Laboratory Information Systems (LIS), POC Controller enables instruments mapping, real-time data centralization, supervise staff skill certifications across one or multiple clinical departments and laboratories. The device does not perform biological sample analysis.
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.