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Terminated

OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)

FDA Recall Z-1042-2007 · Posted 2007-07-13

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2007-03-22
Date Terminated2008-08-15
Product Quantity~33 million vials (25 strips per vial in the US, ~19 million worldwide.

Reason for Recall

Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.

Firm Action

March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone.

Root Cause

Other

Distribution Pattern

Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062195MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc. · 2006-08-16

Official Source

View FDA Recall →

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

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