Recall Z-0295-2008 ยท JBS Timer, General Laboratory
Nova Biomedical Corporation
Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA
| Date | Jan 17, 2008 (initiated Sep 17, 2007) |
| Status | Terminated |
| Reason | Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples |
| Root cause | Device Design |
| Action | Nova issued a Customer Advisory Notice notification by phone on 9/17/07 to contact customers using a script . If the facility reports Normalized Ionized Calcium or Normalized Ionized Magnesium, Nova Biomedical will replace existing stock of Nova 8 calibrator packs. If the facility does not report Normalized Ionized Calcium or Normalized Ionized Magnesium, the account can continue to use the existing lot of calibrator packs.This contact will be documented within the Nova Biomedical complaint database. Intemational Customer Advisory Notice being sent to Nova Biomedical Subsidiariies and Distri |
| Quantity | 2,999 units |
| Distribution | Worldwide, USA, Canada, Argentina, Bangladesh, Bolivia, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France,Germany,Greece, Hungary, India, Indonesia, Ireland,Italy, Japan, Korea, Mexico, Peru, Poland, Scotland, South Africa, Spain, Sri Lanka. Switzerland, Syria ,Taiwan, Turkey and The U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.