FDA Medical Device Recalls (openFDA)
Nova Biomedical Corporation: Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
- Recall number
- Z-0060-04
- Recalling firm
- Nova Biomedical Corporation
- Product
- Stat Profile Ultra Magnesium Sensor (In-vitro Diagnostic used with the Stat Profile Ultra M analyzer) Part # 20394
- Status
- Terminated
- Initiated
- 2003-09-22
- Posted
- 2003-10-24
- Terminated
- 2004-02-04
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K981427"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1219029
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28