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Terminated

LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037

FDA Recall Z-1596-05 · Posted 2005-09-29

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2003-11-21
Date Terminated2005-11-29
Product QuantityApproximately 572,000 units

Reason for Recall

LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails to realize that 18mg/dL of glucose is equal to 1 (one) mmol/L.

Firm Action

Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner''s booklet.

Root Cause

Other

Distribution Pattern

The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner''s Booklets between March 31, 2003 and October 3, 2003.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024194ONE TOUCH ULTRA AND ONE TOUCH INDUO BLOOD GLUCOSE MONITORING SYSTEMSLifescan, Inc. · 2003-02-07

Official Source

View FDA Recall →

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

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