International safety notice

Analizador ORTHO VISION ® (código de producto: 6904579) / ORTHO VISION® Max (código de producto: 6904578) para casetes ORTHO BioVue ®, cuando se procesa la prueba ORTHO™ Sera Anti-Jkb (código de producto: 6904489).

Spain / AEMPS · ESP · Nov 27, 2023

Key facts

Title Analizador ORTHO VISION ® (código de producto: 6904579) / ORTHO VISION® Max (código de producto: 6904578) para casetes ORTHO BioVue ®, cuando se procesa la prueba ORTHO™ Sera Anti-Jkb (código de producto: 6904489).
Regulator Spain / AEMPS
Country ESP
Brand Analizador ORTHO VISION ® (código de producto: 6904579) / ORTHO VISION® Max (código de producto: 6904578) para casetes ORTHO BioVue ®, cuando se procesa la prueba ORTHO™ Sera Anti-Jkb (código de producto: 6904489).
Manufacturer QuidelOrtho (Ortho Clinical Diagnostics Inc), Reino Unido
Models J55655, 10758750013166, 10-14, 28033, 6904578, 10758750012848, 6904579, 28022, 10758750012831, 2023-545, 91.822.52.89, 100166 and 4 more
Event type Safety Notice
Date Nov 27, 2023

At a glance

  • No Recall
  • Yes Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices