Nova Biomedical Corporation Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
Brand
Nova Biomedical Corporation
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Nova Biomedical Corporation is recalling Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer due to Degradation of the magnesium sensor could result in low ionozed magnesium patient samples. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, VA
Page updated: Jan 10, 2026