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Terminated

Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394

FDA Recall Z-0060-04 · Posted 2003-10-24

Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeCHL
Date Initiated2003-09-22
Date Terminated2004-02-04
Product Quantity659 units

Reason for Recall

Degradation of the magnesium sensor could result in low ionozed magnesium patient samples

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981427STAT PROFILE M ANALYZERNova Biomedical Corp. · 1998-05-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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