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

FDA device recall Z-1974-2012 · posted 2012-07-09 · Terminated

Recall details

Recalling firm

Abbott Point Of Care Inc.

Reason for recall

Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.

Action taken

Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.

Root cause

Device Design

Status

Terminated

Product code

CHL

Quantity affected

06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS

Distribution

Worldwide Distribution - USA (nationwide)

Date initiated

2011-09-08

Date posted

2012-07-09

Date terminated

2013-01-28

Location

Princeton, NJ

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