International safety notice

SARS-CoV-2 IgM/IgG Test Rápido de Anticuerpos.

Spain / AEMPS · ESP · Jun 2, 2020

Key facts

Title SARS-CoV-2 IgM/IgG Test Rápido de Anticuerpos.
Regulator Spain / AEMPS
Country ESP
Brand SARS-CoV-2 IgM/IgG Test Rápido de Anticuerpos.
Manufacturer Sure Bio-Tech (USA) Co. Ltd
Models 10240, 221000, RM101, 2020-304, 48163, 2020-295, 2020-306, LANE561, 2020-281, 201314, 2020-300, 2020-298 and 56 more
Event type Safety Notice
Date Jun 2, 2020

At a glance

  • No Recall
  • Yes Field safety notice
  • 100–999 Matching device models in FDA data
  • 10–99 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

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