Z-1791-2010

i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of...

Name: Z-1791-2010 i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of...
Creator: Abbott Point of Care Inc.
Published: 2010-02-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-02-05 / Terminated

FDA source

Abbott Point of Care Inc. began a recall of i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or... on 2010-02-05. The reason FDA records is "Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1791-2010
Status: Terminated
Initiated: 2010-02-05
Posted: 2010-06-11
Terminated: 2012-07-25
Recalling firm: Abbott Medical
Product: i-STAT CHEM8+ cartridges The i-stat Hematocrit (Hct) is intended for use in the in vitro quantification of packed red blood cell volume in arterial, venous, or capillary whole blood. Hematocrit is a key indicator of the body's state of hydration, anemia, or severe blood loss, as well as the blood's ability to transport oxygen.
Product code: JPI Device, Hematocrit Measuring
Reason for recall: Abbott has determined that there is a dependence of the i-STAT Hct assay on the vertical pitch angle of the i-STAT Analyzer during the blood analysis cycle.
FDA root cause: Other
Action: The firm, Abbott Point of Care, sent an "Urgent Field Safety Notice Product Recall" letter dated January 2010 to the customers. Safety Alert /Product Recall letters were also sent by Federal Express commencing on February 5, 2010. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to replace the i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB /Cartridge and Test Information (CT) Sheet found in their i-STAT System manual with those included in the mailing , and to provide a copy of the letter another facility, if they have forwarded any cartridges. If you should have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020 or your Abbott Point of Care representative.
Quantity in commerce: 40,446 catridges total, all varieties
Distribution: Worldwide distribution: USA and Argentina; Austria; Bahamas; Bolivia; Brazil; Chile; Hong Kong; China; China; Columbia; Costa Rica; Denmark; Dominican Republic; Ecuador; El Salvador; Finland; Georgia; Greece; Honduras; India; India; Ireland; Israel; Italy; Japan; Kuwait; Mauritius; Mexico; Norway; Oman; Panama; Paraguay; Peru; Poland; Portugal; Qatar; Russian Federation; Saudi Arabia; Singapore; South Africa; South Korea; Spain; Switzerland; Taiwan; Thailand; Trinidad and Tobago; Turkey; United Arab Emirates; Uruguay; Yemen; Netherlands Antilles; Venezuela; Australia; Belgium; France; Germany; Italy; New Zealand; Spain; Sweden; and The Netherlands.
Product codes and lots: List # 03M88-01, 02

Product code JPI

K053110Class IIAbbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ CartridgeI-Stat Corporation / cleared 2006-01-13

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)