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.
- Company
- Nova Biomedical Corporation
- Recall Initiated
- February 12, 2010
- Posted
- June 10, 2010
- Terminated
- July 22, 2011
- Recall Number
- Z-1783-2010
- Quantity
- 392 Cases (1800 strips each)
- Firm Location
- Waltham, MA
Reason for Recall
Glucose strips report low glucose results
Distribution
Worldwide Distribution -- United States (CO, MA, MN and RI), United Kingdom, Germany, France and Italy.
Lot / Code Info
Lot Number: 0309019249, Expiration Date: 1/31/2011.
Root Cause
Nonconforming Material/Component
Action Taken
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.
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