LifeScan OneTouch Ultra Test strips, lot number 2528640
FDA Recall Z-0435-06 · Posted 2006-01-24
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Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeCGA
Date Initiated2005-11-01
Date Terminated2006-07-26
Product Quantity7321 boxes of 100 count test strips (29338 vials)
Reason for Recall
Product may be defective and may give low inaccurate glucose results.
Firm Action
Recall was initiated in early November. Notifications were sent on November 21, 2005. The firm has also posted recall notices on its website, and Customer Service Scripting will be available to address questions from callers.
Root Cause
Other
Distribution Pattern
7 direct consignees (2 wholesale dealers and 5 distributors_ located in CA, PA, IL, WI, MN, SD, OK, CN, MA, MI.
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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