Z-0812-2010

i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is...

Name: Z-0812-2010 i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is...
Creator: Abbott Point of Care Inc.
Published: 2009-09-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-09-09 / Terminated / root cause: labeling and UDI

FDA source

Abbott Point of Care Inc. began a recall of i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals... on 2009-09-09. The reason FDA records is "The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0812-2010
Status: Terminated
Initiated: 2009-09-09
Posted: 2010-02-24
Terminated: 2014-12-08
Recalling firm: Abbott Medical
Product: i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: An "Urgent Recall Notice" was issued to customers during September 2009. The letter described the affected product, issue and recommended actions. Customers were asked to verify storage conditions on the box are correct and if not, discard the outside box. If the customer requires a replacement box, the customer must contact Abbott Point of Care Technical Support. Direct questions and requests for additional information to the Abbott Point of Care Technical Support by calling 1-800-366-8020, Option 1 or contact your Abbott Point of Care representative.
Quantity in commerce: 3,918 analyzers
Distribution: Worldwide Distribution (including the United States).
Product codes and lots: Catalog number 06F16-10.

Product code CGA

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)