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Recall Observatory FDA recall evidence

Device product

Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)

Z-1154-2013

February 25, 2013

Class II

Product summary

Firm
Nova Biomedical Corporation
Event
Event 64638
Status
Terminated
Classification
Class II
Quantity
2200 cases
Official record key
device-enforcement:Z-1154-2013

Official wording

Reason: Glucose test strips reports no result message when tested

Code information: Lot 0312361309, Expires 6/30/2015 Expanded recall: Lot 0313021309, Expires 07/31/2015

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA, IL, KY,NY, WV and countries of: United Kingdom and Italy.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Glucose test strips reports no result message when tested