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Recall Observatory FDA recall evidence

Device product

i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of arterial, venous, or capillary whole blood 510 K940918 Model 300. The i-Stat Model 300 Portable Clinical Analyzer is intended to be used by trained medical professional for use with i-Stat test cartridges and MediSense blood glucose test strips. i-State cartridges comprise a variety of clinical chemistry tests and test panels. 510K 001387

Z-1977-2012

September 08, 2011

Class II

Product summary

Firm
Abbott Point Of Care Inc.
Event
Event 62319
Status
Terminated
Classification
Class II
Quantity
04J48-201-1069 units; 215001-217 units
Official record key
device-enforcement:Z-1977-2012

Official wording

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

Code information: Military Kit iStat1 04J48-201 215001 All lots

Distribution pattern: Worldwide Distribution - USA (nationwide)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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