Z-1328-2009

Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog #...

Name: Z-1328-2009 Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog #...
Creator: Nova Biomedical Corporation
Published: 2008-08-11
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2008-08-11 / Terminated / root cause: manufacturing process

FDA source

Nova Biomedical Corporation began a recall of Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health... on 2008-08-11. The reason FDA records is "Erroneous, low creatinine results on CCX analyzer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1328-2009
Status: Terminated
Initiated: 2008-08-11
Posted: 2009-05-07
Terminated: 2011-07-22
Recalling firm: Nova Biomedical Corporation
Product: Stat Profile Critical Care Xpress (CCX and CCX+), CCX Creatinine Membrane Kit for CCX analyzer Catalog # 35238 Intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Ca++, total hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), reduced hemoglobin (HHb), Oxygen content (O2Ct) and Oxygen capacity (O2Cap) in heparinized whole blood; Na+, K+, CL-; Ca++, Mg++, Glucose heparinized whole blood, serum, or plasma.
Product code: CGL Electrode, Ion Based, Enzymatic, Creatinine
Reason for recall: Erroneous, low creatinine results on CCX analyzer
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Initial: USA and Canada - Customer Advisory Notice notification by phone contact with key customer contact facilitated using a Field Correction Script. This contact will be documented within the Nova Biomedical Technical Support database (Pivotal) and on a Field Correction Checklist. All affected inventory will be replaced at customer sites. International - Customer Advisory Notice and Faxback Form being communicated and sent to Nova Biomedical Subsidiaries and Distributors by three methods of delivery (Email, Fax and Phone Call). Follow-up: USA and Canada - Sending the Customer Advisory Notice by email and/or fax to the key customer contact from the initial phone contact. International - Sending the Customer Advisory Notice by email and/or fax to the key contact.
Quantity in commerce: 1230
Distribution: Worldwide Distribution -- USA, Canada, Germany, France, Czech Republic, Taiwan, Japan, Thailand, Italy, Hungary, India, UK, Ireland, Venezuela, Brazil, and Hong Kong.
Product codes and lots: Lots 806050, 806182, 806242, 806567, 806721, 806752, and 807246.

Product code CGL

K022746Class IIStat Profile Critical Care Xpress AnalyzerNova Biomedical Corp. / cleared 2002-11-22

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)