Z-1171-06

i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer...

Name: Z-1171-06 i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer...
Creator: Abbott Laboratories
Published: 2006-05-24
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-05-24 / Terminated

FDA source

Abbott Laboratories began a recall of i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor... on 2006-05-24. The reason FDA records is "Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1171-06
Status: Terminated
Initiated: 2006-05-24
Posted: 2006-06-22
Terminated: 2007-08-15
Recalling firm: Abbott Medical
Product: i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catalog Number -- 220300; Abbott List Number (US and Canada)-- 06F01-01; Abbott List Number (Rest of World) -- 06F01-02.
Product code: JGS Electrode, Ion Specific, Sodium
Reason for recall: Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained
FDA root cause: Other
Action: Recall letters were sent out via federal express and email notification was sent electronically with instructions as attachments during the period of 5/8/2006 through 6/7/2006 to include stop useage, and hold for replacement.
Quantity in commerce: 59775 cartridges
Distribution: World wide ---There is only one US customer for these lots. The rest are international customers (Germany, Turkey, Hong Kong, Japan, Canada). There are no government accounts.
Product codes and lots: Lot Number -- Expiration Date: U06024B -- exp. date 09/14/06; U06037C -- exp. date 09/28/06; U06062A -- exp. date 10/28/06; U06063 -- exp. date 10/28/06.

Product code JGS

K894914Class IIModel 100 Portable Clinical Analyzer and Test PackI-Stat Corp. / cleared 1989-10-16

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)