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U.S. Department of Health and Human Services

Class 3 Device Recall Nova Biomedical

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  Class 3 Device Recall Nova Biomedical see related information
Date Initiated by Firm September 17, 2007
Date Posted January 17, 2008
Recall Status1 Terminated 3 on March 16, 2012
Recall Number Z-0295-2008
Recall Event ID 44941
Product Classification Sodium Test System calibrator - Product Code JBS
Product Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA
Code Information Lot Numbers: 610633, 701034, 704053, 707222
Recalling Firm/
Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453-3457
For Additional Information Contact
781-894-0800 Ext. 211
Manufacturer Reason
for Recall
Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples
FDA Determined
Cause 2
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 Distributors by Federal Express Envelope.The Federal Express envelopes tracking number will be used for delivery confirmation.
Quantity in Commerce 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 United Kingdom
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.