Recall Z-1975-2012— Abbott Point Of Care Inc.

Name: FDA recall Z-1975-2012
Creator: U.S. Food and Drug Administration
Published: 2011-09-08

Class II · Terminated

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2011-09-08, terminated 2013-01-28. It names one FDA 510(k) clearance: K001387. Product: Fuso Analyzer 300F; 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. Reason: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension..

Recalling firm: Abbott Point Of Care Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-09-08
Terminated: 2013-01-28
Firm location: Princeton, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K001387 — I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300I-Stat Corp.·cleared 2000-10-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fuso Analyzer 300F; 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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.