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Terminated

LifeScan OneTouch Ultra Primary Care Physician Demo Kits, Blood Glucose Meter

FDA Recall Z-0272-06 · Posted 2005-12-08

Recalling FirmLifescan Inc
Recall StatusTerminated
Product CodeNBW
Date Initiated2005-10-10
Date Terminated2006-11-21
Product Quantity2843 kits

Reason for Recall

Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters

Firm Action

A notification letter dated October 10, 2005 was issued to all health care professionals that requested the demo kit.

Root Cause

Other

Distribution Pattern

Distributed to 2843 total consignees, 2568 HCPs and 275 sales representatives throughout the USA, no foreign distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043197ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc. · 2005-05-20

Official Source

View FDA Recall →

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

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