International safety notice

Corrective action / recall for all PT- / APTT-based IL Locked Test Groups on ACL Elite, ACL Elite Pro, ACL 8000, ACL 9000 and ACL 10000 Coagulation Analyzers, Instrumentation Laboratory

Germany / BfArM · DEU · Jan 27, 2012

Key facts

Title Corrective action / recall for all PT- / APTT-based IL Locked Test Groups on ACL Elite, ACL Elite Pro, ACL 8000, ACL 9000 and ACL 10000 Coagulation Analyzers, Instrumentation Laboratory
Regulator Germany / BfArM
Country DEU
Brand all PT- / APTT-based IL Locked Test Groups on ACL Elite, ACL Elite Pro, ACL 8000, ACL 9000 and ACL 10000 Coagulation Analyzers, Instrumentation Laboratory
Manufacturer Corrective action / recall for all PT- / APTT-based IL Locked Test Groups on ACL Elite, ACL Elite Pro, ACL 8000, ACL 9000 and ACL 10000 Coagulation Analyzers, Instrumentation Laboratory
Models 21.24, 02.00.00, 10.27, 0009831704, 02.01.00, 10.04, 11.57, 10000, CLEANINGA2, 11.34, 0009832700, 12.64 and 2 more
Date Jan 27, 2012
Regulator page bfarm.de

At a glance

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