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Old 12-03-2008, 11:44 AM
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Default Re: Important Recalls and Warnings - Food, Meds, Etc.

http://www.fda.gov/bbs/topics/ENFORC.../ENF01083.html

FDA Enforcement Report November 26, 2008

PRODUCT

One Touch Ultra Test Strips, part number 020-994-02, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use 0outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm, Recall # Z-0004-2009

CODE

Lot number: 2829235

RECALLING FIRM/MANUFACTURER

Lifescan Inc., Milpitas, CA, by letters, dated September 19, 2008. Firm initiated recall is ongoing.

REASON

Products exceed inaccuracy threshold, with many complaints resulting from inaccurate low results.

VOLUME OF PRODUCT IN COMMERCE

35,308 vials

DISTRIBUTION

Nationwide and PR