Exact FDA event identifier

Event 62319

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 08, 2011
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Abbott Point Of Care Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

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.

Z-1973-2012

Recall number: Z-1973-2012
Initiated: September 08, 2011
Classification: Class II
Status: Terminated
Recalling firm: Abbott Point Of Care Inc.
Quantity: 06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

510K K940918 Product Number/List Number 06F16-05; 06F16--10; 310000; 310001;; 310002 All lots

Distribution pattern

Worldwide Distribution - USA (nationwide)

device · product 2 of 6

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

Z-1974-2012

Recall number: Z-1974-2012
Initiated: September 08, 2011
Classification: Class II
Status: Terminated
Recalling firm: Abbott Point Of Care Inc.
Quantity: 06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

i-Stat Portable Clinical Analyzer 06F16-02 210000 210001 210002 210003 All lots

Distribution pattern

Worldwide Distribution - USA (nationwide)

device · product 3 of 6

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

Z-1975-2012

Recall number: Z-1975-2012
Initiated: September 08, 2011
Classification: Class II
Status: Terminated
Recalling firm: Abbott Point Of Care Inc.
Quantity: 310003 -2203 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

FUSO Analyzer 300F 310003 All lots

Distribution pattern

Worldwide Distribution - USA (nationwide)

device · product 4 of 6

i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540

Z-1976-2012

Recall number: Z-1976-2012
Initiated: September 08, 2011
Classification: Class II
Status: Terminated
Recalling firm: Abbott Point Of Care Inc.
Quantity: 6000-0000-650 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

i-Stat1 Abaxis Analyzer 6000-0000 All lots

Distribution pattern

Worldwide Distribution - USA (nationwide)

device · product 5 of 6

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

Recall number: Z-1977-2012
Initiated: September 08, 2011
Classification: Class II
Status: Terminated
Recalling firm: Abbott Point Of Care Inc.
Quantity: 04J48-201-1069 units; 215001-217 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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)

device · product 6 of 6

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

Z-1978-2012

Recall number: Z-1978-2012
Initiated: September 08, 2011
Classification: Class II
Status: Terminated
Recalling firm: Abbott Point Of Care Inc.
Quantity: 04J48-01-56 units; 215000-695 units

App-derived interpretation

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Military Kit Portable Clinical Analyzer 04J48-01 215000 All lots

Distribution pattern

Worldwide Distribution - USA (nationwide)