Stat Profile Critical Care Expres Ionized Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Critical Care Xpress Analyzer) Part # 37271
- Company
- Nova Biomedical Corporation
- Recall Initiated
- September 22, 2003
- Posted
- October 24, 2003
- Terminated
- February 4, 2004
- Recall Number
- Z-0061-04
- Quantity
- 280 units
- Firm Location
- Waltham, MA
Reason for Recall
Degradation of the magnesium sensor could result in low ionozed magnesium patient samples
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
Lot / Code Info
Lot Number Exp. Date 304828 7/31/04 304543 7/31/04 304296 7/31/04 303793 6/30/04 303519 6/30/04 303401 6/30/04 302670 5/31/04 302242 5/31/04 301126 4/30/04 212130 3/31/04 211349 2/29/04
Root Cause
Other
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.