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Terminated

Nova StatStrip Glucose Test Strips, Catalog Number: 42214. Nova Biomedical Corporation. Waltham, MA 02454. Intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial and neonate whole blood.

FDA Recall Z-1783-2010 · Posted 2010-06-10

Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeCGA
Date Initiated2010-02-12
Date Terminated2011-07-22
Product Quantity392 Cases (1800 strips each)

Reason for Recall

Glucose strips report low glucose results

Firm Action

Nova Biomedical notified it's domestic Consignees by a Customer Advisory Notice by phone and follow up by email and/or fax dated February 12, 2010. The firm will replace all affected inventory at customer sites via overnight shipment of replacement Test Strips to customer site. For further information, contact your local Nova Support Department or call 1-800-545-6682.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070960NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corp. · 2007-07-11K063821NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEMNova Biomedical Corp. · 2007-01-24K060345NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONSNova Biomedical Corp. · 2006-04-28

Official Source

View FDA Recall →

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

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