Z-0060-04

Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part #...

Name: Z-0060-04 Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part #...
Creator: Nova Biomedical Corporation
Published: 2003-09-22
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2003-09-22 / Terminated

FDA source

Nova Biomedical Corporation began a recall of Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394 on 2003-09-22. The reason FDA records is "Degradation of the magnesium sensor could result in low ionozed magnesium patient samples". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0060-04
Status: Terminated
Initiated: 2003-09-22
Posted: 2003-10-24
Terminated: 2004-02-04
Recalling firm: Nova Biomedical Corporation
Product: Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
FDA root cause: Other
Action: Nova Biomedical contacted customers by telephone beginning on 9/26/03. Each account was faxed or mailed Customer Information Bulletin requesting the discard of Mg++ sensors in inventory that are greater than 4 months old from date of manufacture. Replacement product will be issued.
Quantity in commerce: 659 units
Distribution: Natinwide Foreign: Italy, Czech, Japan, Taiwan, Hungary, India, Israel, Mexico, Canada, Germany,Switzerland, Tunisia, Korea, Brazil, Greece, Coatia, China, France, Turkey, Thailand, Argentina. Government: VA Decator, GA
Product codes and lots: Lot Number Exp. Date 304716 2/29/04 304074 2/29/04 303798 1/31/04 303515 1/31/04 303479 1/31/04 303222 1/31/04 302808 12/31/03 302652 12/31/03 302267 12/31/03 301844 11/30/03 301443 11/30/03 301219 11/30/03 212490 10/31/03 212332 10/31/03 212043 10/31/03 211170 9/30/03

Product code CHL

K981427Class IIStat Profile M AnalyzerNova Biomedical Corp. / cleared 1998-05-12

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)