Abbott Point Of Care Inc.: Medical Device Recall in 2012 - (Recall #: Z-1977-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 8, 2011

Date Posted: July 18, 2012

Recall Number: Z-1977-2012

Event ID: 62319

Reason for Recall:

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

Status: Terminated

Product Quantity: 04J48-201-1069 units; 215001-217 units

Code Information:

Military Kit iStat1 04J48-201 215001 All lots

Distribution Pattern:

Worldwide Distribution - USA (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated