OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
FDA Recall Z-1070-2009 · Posted 2009-03-17
Advertisement
Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2008-11-25
Date Terminated2010-12-06
Product Quantity23,288 vials
Reason for Recall
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
Firm Action
Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall.
Root Cause
Process design
Distribution Pattern
Worldwide Distribution -- USA and the Caribbean.
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.
Advertisement