Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
- Company
- Nova Biomedical Corporation
- Recall Initiated
- September 22, 2003
- Posted
- October 24, 2003
- Terminated
- February 4, 2004
- Recall Number
- Z-0060-04
- Quantity
- 659 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 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
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.