FDAClass IIJuly 18, 2012

i-Stat Portable Clinical Analyzer recall

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

Why was i-Stat Portable Clinical Analyzer recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

i-Stat Portable Clinical Analyzer 06F16-02 210000 210001 210002 210003 All lots

Product
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium…
Recalling firm
Abbott Point Of Care Inc.
Quantity
06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS
Distribution
Worldwide Distribution - USA (nationwide)
Recall date
July 18, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls