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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62319

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

Open FDA event record

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)

Field note

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