SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.
FDA Recall Z-1546-05 · Posted 2005-09-15
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Recalling FirmCHdiagnostics
Recall StatusTerminated
Product CodeLFR
Date Initiated2005-03-14
Date Terminated2007-01-23
Product Quantity43,138 vials
Reason for Recall
A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.
Firm Action
Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots.
Root Cause
Other
Distribution Pattern
AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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