FDAFDA · Food and drugs·Recall number Z-1978-2012
Military Kit Portable Clinical 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
Published July 18, 2012 · Recall initiated: September 8, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Point Of Care Inc.
- Distributor
- Worldwide Distribution - USA (nationwide)
- Lot
- Military Kit Portable Clinical Analyzer 04J48-01 215000 All lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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