International safety notice

- Kit BlueDiver Dot Polymyositis/Scleroderma12 IgG, referencia PMS12DIV-24, lote DK 240518. - Kit BlueDiver Quantrix ANA25 Screen IgG, referencia ANA25Q-24, lote EA240598.

Spain / AEMPS · ESP · Jul 8, 2024

Key facts

Title - Kit BlueDiver Dot Polymyositis/Scleroderma12 IgG, referencia PMS12DIV-24, lote DK 240518. - Kit BlueDiver Quantrix ANA25 Screen IgG, referencia ANA25Q-24, lote EA240598.
Regulator Spain / AEMPS
Country ESP
Brand - Kit BlueDiver Dot Polymyositis/Scleroderma12 IgG, referencia PMS12DIV-24, lote DK 240518. - Kit BlueDiver Quantrix ANA25 Screen IgG, referencia ANA25Q-24, lote EA240598.
Manufacturer D-Tek s.a, Bélgica.
Models 2024-357, DK240518, EA240598, ANA25Q-24, PMS12DIV-24, 91.822.52.89, 28022, SCLERODERMA12, 08908, 240621-1, 108169, 1-07-2024 and 4 more
Event type Safety Notice
Date Jul 8, 2024

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