Z-1975-2012Class II

Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium...

Name: Z-1975-2012 Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium...
Creator: Abbott Point Of Care Inc.
Published: 2011-09-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-09-08 / Terminated / root cause: design

FDA source

Abbott Point Of Care Inc. began a recall of 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... on 2011-09-08. FDA classified it as Class II and gives the reason as "Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1975-2012
Classification: Class II
Status: Terminated
Initiated: 2011-09-08
Posted: 2012-07-09
Terminated: 2013-01-28
Recalling firm: Abbott Medical
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
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Some i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Root cause tag: design
FDA root cause: Device Design
Action: Abbott Point Care sent an Urgent Product Recall letter dated September 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to confirm the number of affected product at their facility that were using the Old Battery Carrier. Fill out the affected Buesiness Reply Card and submit their facility information as per the instructions on the card. Upon the receipt of the New Battery Carriers, replace the Old Battery Center with the New Battery Center. Customers were instructed to immediately dispose of all Old Battery Carriers per local regulations. If customers forward the affected product to another facility, they should provide a copy of the recall letter to them and advise them to replace the carriers if required. For any questions call 800-366-8020, Option 1 or your Abbott Point of Care representative. For questions regarding this recall call 609-454-9272.
Quantity in commerce: 310003 -2203 units
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: FUSO Analyzer 300F 310003 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1975-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1973-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1974-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1975-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1976-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1977-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09
Z-1978-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-09

Product code CHL

K001387Class III-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. / cleared 2000-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)