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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Event Detail

Event ID 62319
Product Type Devices
Status Ongoing
Recalling Firm Abbott Point Of Care Inc.
City Princeton
State NJ
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-09-08
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - USA (nationwide)

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Military Kit Portable Clinical Analyzer 04J48-01 215000 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. 04J48-01-56 units; 215000-695 units Z-1978-2012
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 Military Kit iStat1 04J48-201 215001 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. 04J48-201-1069 units; 215001-217 units Z-1977-2012
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 i-Stat1 Abaxis Analyzer 6000-0000 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. 6000-0000-650 units Z-1976-2012
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 FUSO Analyzer 300F 310003 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. 310003 -2203 units Z-1975-2012
i-Stat 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 i-Stat Portable Clinical Analyzer 06F16-02 210000 210001 210002 210003 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. 06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS Z-1974-2012
iStat1 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 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 K940918 Product Number/List Number 06F16-05; 06F16--10; 310000; 310001;; 310002 All lots Class II Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension. 06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units Z-1973-2012
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