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Terminated

Nova 8 Analyzer Calibrator Pack (Catalog/REF # 15196), Nova Biomedical, Waltham, MA

FDA Recall Z-0295-2008 · Posted 2008-01-17

Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeJBS
Date Initiated2007-09-17
Date Terminated2012-03-16
Product Quantity2,999 units

Reason for Recall

Elevated Normalized Ionized Calcium (nCa) and Normalized Ionized Magnesium (nMg) calculated values on patient samples

Firm 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.

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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