Device recall: iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium…

Class II FDA enforcement event 62319. Recall start date: 8 Sep 2011. Status in the FDA record: Terminated. Termination date: 28 Jan 2013.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Abbott Point Of Care Inc. started this device recall on 8 Sep 2011. The firm address in the FDA record is in Princeton, NJ. FDA put the recall in Class II. FDA event 62319 has 6 product records. The first FDA enforcement report date is 18 Jul 2012. The record gives the status Terminated, with the termination date 28 Jan 2013.

FDA enforcement report The 6 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - USA (nationwide)

Recalling firm

Abbott Point Of Care Inc., Princeton, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 62319: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1973-2012	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…	06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units	Class II	Terminated	18 Jul 2012
Z-1974-2012	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…	06F16-02-1295 UNITS; 210000-1076 UNITS; 210001-447 UNITS; 210002-5359 UNITS; 210003-9051 UNITS	Class II	Terminated	18 Jul 2012
Z-1975-2012	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…	310003 -2203 units	Class II	Terminated	18 Jul 2012
Z-1976-2012	i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540	6000-0000-650 units	Class II	Terminated	18 Jul 2012
Z-1977-2012	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…	04J48-201-1069 units; 215001-217 units	Class II	Terminated	18 Jul 2012
Z-1978-2012	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…	04J48-01-56 units; 215000-695 units	Class II	Terminated	18 Jul 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2011: 114
Share of these events in Class II: 89%
Product records in this event: 6Median of the firm: 1
Events of the firm on the register: 18

Other events of the firm

Other FDA enforcement events of Abbott Point Of Care Inc.
Initiated	Product (first record)	Type	Class	Records
1 Apr 2026	i-STAT EG7+ cartridge; List Number: 03P76-25;	Device	Class II	3
21 Aug 2025	i-STAT CG4+ cartridge (white). List Number: 03P85-25.	Device	Class II	1
21 Aug 2025	i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300	Device	Class II	3
22 Dec 2020	Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose	Device	Class II	2
15 Jan 2020	i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge	Device	Class II	2
14 Jan 2020	i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 00054749002283 - Product Usage: The i-STAT G3+ cartridge may be	Device	Class II	1
16 Oct 2019	i-STAT cTnI cartridge	Device	Class II	1
13 Sep 2018	Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quantification of potassium in arterial, venous, or capil	Device	Class II	1
12 Sep 2017	i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054	Device	Class II	1
15 Jun 2015	i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24	Device	Class II	1

Abbott Point Of Care Inc.: all 18 events

Official channels

FDA enforcement report Z-1973-2012The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 62319. https://recallregister.com/fda/ii/62319/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - USA (nationwide)
What quantity of product is in FDA event 62319?: The event has 6 product records. The first record gives this quantity: 06F16-05-45 units; 06F16-10-22289units; ;310000-4393 units; 310001-1139 units; 310002-11489 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2011 have the same class?: 89% of the 114 device events that started in 2011 are in Class II.