Z-1621-2011

i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT...

Name: Z-1621-2011 i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT...
Creator: Abbott Point Of Care Inc.
Published: 2006-09-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-09-25 / Terminated

FDA source

Abbott Point Of Care Inc. began a recall of i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro... on 2006-09-25. The reason FDA records is "Certain lots of G3+ cartridges may be difficult to fill". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1621-2011
Status: Terminated
Initiated: 2006-09-25
Posted: 2011-03-10
Terminated: 2012-02-27
Recalling firm: Abbott Medical
Product: i-STAT G3+ Cartridge: PCO2 Abbott Point of Care, Princeton, NJ 08540 The test for PCO2, as part of the i-STAT System, is intended for use in the in vitro quantification of carbon dioxide partial pressure in arterial, venous or capillary whole blood. PCO2 along with pH is used to assess acid-base balance.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Certain lots of G3+ cartridges may be difficult to fill.
FDA root cause: Other
Action: The firm, Abbott Point of Care, sent a "Important notice" letter dated September 25, 2006 to all customers. The letter described the product, problem and actions to be taken. The customers were to destroy and discard the i-STAT G3+ Cartridges and complete and return the customer reply form. Abbott sent replacements cartridges to their customers. If you or any of the healthcare providers you serve have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1.
Quantity in commerce: 12,675 in US, 125 ROW
Distribution: Worldwide distribution: USA and country of : Canada.
Product codes and lots: Catalog number: 06F03-1, 06F03-02; Lot numbers: J06072, Exp 10/28/2006; J06076, Exp 11/14/2006; J06081, Exp 11/14/2006; J06083, Exp 11/14/2006; J06085, Exp 11/14/2006.

Product code CHL

K940918Class III-Stat 200 Portable Clinical AnalyzerI-Stat Corp. / cleared 1994-05-10

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)