EVOYA Platform
Wallac Oy · Model 5021-1000 · UDI-DI 06438147366804
JQP
Prescription
10
510(k) clearances
2,167
Adverse events (5 deaths)
220
Recalls
117
Facilities
Description
The Evoya Software Platform is an in vitro diagnostics modular software intended to be used together with Neonatal screening assay systems to enable workflow activities, data management, results analysis and reporting. The EVOYA Software Platform is intended to be used by trained laboratory professionals. The Evoya Software Platform is intended for in vitro diagnostic use.
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.