i-STAT Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree 37 degree C tests

FDA device recall Z-0597-2011 · posted 2010-12-10 · Terminated

Recall details

Recalling firm

Abbott Point Of Care Inc.

Reason for recall

i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.

Action taken

Abbott Point of Care issued Urgent Recall Notice letters dated September 20, 2010 to customers. The letter informs users to of the possibility of the unit becoming hot to touch, to remove the unit if this is the case, not to remove batteries unless instructed to do by APOC and to forward notification of the recall to customers if it has been further distributed. Abbott Point of Care can be contacted at 800 366-8020, option 1, about this action. Recall extended in May 2011 to included distribution dates of 9/20/2010-6/6/2011.

Root cause

Other

Status

Terminated

Product code

CGA

Quantity affected

06F16-02- 1295: 210000 - 1076; 210001 - 447; 210002 - 5339; 210003 - 9051.

Distribution

Worldwide Distrbution: Throughout USA and the countries of Argentina, Australia, Austria, Belgium.Bolivia, Bosnia-Herz, Canada. Croatia, Chile, Colombia, Costa Rica, Denmark, Ecuador, El Salvador, Fin

Date initiated

2010-09-20

Date posted

2010-12-10

Date terminated

2013-01-28

Location

Princeton, NJ

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