Recall Z-0060-04 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Nova Biomedical Corporation
Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
| Date | Oct 24, 2003 (initiated Sep 22, 2003) |
| Status | Terminated |
| Reason | Degradation of the magnesium sensor could result in low ionozed magnesium patient samples |
| 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981427 | STAT PROFILE M ANALYZER Nova Biomedical Corp., May 12, 1998 |