Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
FDA device recall Z-0060-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Nova Biomedical Corporation
- Reason for recall
- Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
- Action taken
- 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
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 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. Governm
- Date initiated
- 2003-09-22
- Date posted
- 2003-10-24
- Date terminated
- 2004-02-04
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAT PROFILE M ANALYZER (K981427) | Nova Biomedical Corp. | 1998-05-12 |