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Terminated

LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

FDA Recall Z-0452-2007 · Posted 2007-01-05

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2006-09-29
Date Terminated2007-11-27
Product Quantity26,398 units (both recall numbers Z-0452/3-2007

Reason for Recall

Inaccurage test results: testing may lead to no test results, error message or inaccurately low test results.

Firm Action

The firm has issued notification on 9/29/06 to consumers and hospital end users known to the firm and direct accounts that received the recalled product. The firm also posted the notice on the website, and customer service scripting was developed to notify callers.

Root Cause

Other

Distribution Pattern

Nationwide to Al, AZ, CA, CN, DE, FL, GA, IL, IN, KT, KY, LA, MA, MD, MI, MN, MS, MO, NE, NJ, NM, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022724SURESTEP BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc. · 2002-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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