Z-0930-2011

i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT...

Name: Z-0930-2011 i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT...
Creator: Abbott Point of Care Inc.
Published: 2010-08-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-08-03 / Terminated

FDA source

Abbott Point of Care Inc. began a recall of i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the vitro quantification... on 2010-08-03. The reason FDA records is "Two cartridge lots were identified that may generate falsely elevated PCO2 results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0930-2011
Status: Terminated
Initiated: 2010-08-03
Posted: 2011-01-20
Terminated: 2011-12-05
Recalling firm: Abbott Medical
Product: i-STAT G3+ Cartridge; pH, pCO2, PO2; IVD Abbott Point of Care The test for PCO2, as part of the i-STAT System, is intended for use in the 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: Two cartridge lots were identified that may generate falsely elevated PCO2 results.
FDA root cause: Other
Action: Abbott Point of Care Inc. sent an Urgent Recall Notice letter dated July 2010 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the cartridges from the identified lots and follow the instructions on the enclosed reply card to receive replacement cartridges. If cartridges were distributed from the lot numbers to another institution, a copy of the recall letter should be provided to them. For any questions regarding this recall contact Abbott-Point of Care Technical Support at 800-366-8020, Option 1.
Quantity in commerce: 55350 total cartridges
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV, and WY and the countries of Oman and Turkey.
Product codes and lots: 06F01-01, 06F03-02; Lot number: P10033

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