Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-03-02 | VAI | Voluntary action indicated | Aesku Group GmbH & Co. KG | 2 |
Similar devices
- ANA Screen IgG ELISA DRG International Inc
- ANA Screen IgG ELISA DRG Instruments Gesellschaft mit beschränkter Haftung
- AccuDiag™ ENA Profile-6 (Sm/RNP, Sm, Jo-1, Scl-70, SS-A, SS-B) ELISA Diagnostic Automation, Inc.
- Anti-ENA Pool ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- Anti-Jo-1 ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- Anti-SS-A ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- Anti-SS-B ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- Anti-Scl-70 ELISA (IgG) EUROIMMUN Medizinische Labordiagnostika AG
- Aptiva® CTD Essential Reagent INOVA DIAGNOSTICS, INC.
- Autoimmune EIA BIO-RAD LABORATORIES, INC.
- Autoimmune EIA BIO-RAD LABORATORIES, INC.
- Autoimmune EIA BIO-RAD LABORATORIES, INC.
Select up to two to place side-by-side with this device.