Z-0726-2008

Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454

Name: Z-0726-2008 Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454
Creator: Nova Biomedical Corporation
Published: 2007-11-02
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2007-11-02 / Terminated / root cause: design

FDA source

Nova Biomedical Corporation began a recall of Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454 on 2007-11-02. The reason FDA records is "Incorrect Results - Creatinine results were lower than the laboratory reference method". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0726-2008
Status: Terminated
Initiated: 2007-11-02
Posted: 2008-02-16
Terminated: 2008-12-09
Recalling firm: Nova Biomedical Corporation
Product: Nova - EZ CHEM Linearity Solution P/N 9618, Nova Biomedical, Waltham, MA 02454
Product code: CGL Electrode, Ion Based, Enzymatic, Creatinine
Reason for recall: Incorrect Results - Creatinine results were lower than the laboratory reference method.
Root cause tag: design
FDA root cause: Device Design
Action: Nova Biomedical issued an Urgent: Medical Device Recall notification letter to consignees dated November 19, 2007. The letter addressed the issues with the product(s) and requested that if users had any remaining stock that it must be returned. The firm also provided a Customer Response form to be returned. Questions concerning this recall will be addressed by Gina Vogelsberg at 1-800-544-4624 or by email at [email protected].
Quantity in commerce: 286 units
Distribution: Nationwide Distribution, including the state of NY
Product codes and lots: Lot Numbers: 4307236990 and 4307270990

Product code CGL

K070068Class IINova Statsensor Creatinine Hospital Meter, Control Solutions,linearity Solutions, and Test StripsNova Biomedical Corp. / cleared 2007-05-07

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)