Z-1153-2013 Class II Terminated
FDA device recall Z-1153-2013 was initiated by Nova Biomedical Corporation on February 25, 2013 and is designated Class II. Reason for recall: Glucose test strips reports no result message when tested The recall status is terminated (terminated September 26, 2014). Affected quantity: 7433 cases.
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2013
- Initiation Date
- February 25, 2013
- Termination Date
- September 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7433 cases
Product Description
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Reason for Recall
Glucose test strips reports no result message when tested
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.
Code Information
Lot 0312349249, Expires 12/31/2014 and Lot 0312361309, Expires 06/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015