Events

Recall of Device Recall LifeScan

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lifescan Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32360
  • Event Risk Class
    Class 2
  • Event Number
    Z-0980-05
  • Event Initiated Date
    2005-06-09
  • Event Date Posted
    2005-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39887
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Reason
    Meter labeling (owner's booklet and quick reference guide) is incorrect as it indicates that the meter displays the message 'do you need a snack' for glucose values between 20 and 70 mg/dl; whereas the onetouch ultrasmart meter displays the message, 'do you need a snack?' for glucose values from 20 through 59 mg/dl.
  • Action
    On 6/9/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.

Device

Device Recall LifeScan
  • Model / Serial
    All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction.  Part Number: Description: 020-524-01, System,OUS,US; 020-524-01F, System,OUS,US; 020-524-01Y, UltraSmart Meter; 020-524-02, System,OUS,EAS-C,US; 020-524-03, System,OUS,EAS-S,US; 020-524-04F, OT UltraSmart System Kit V. 4 USA; 020-524-04Y, UltraSmart System; 020-524-05, UltraSmart System -EAS-C; 020-524-06, UltraSmart System -EAS-S; 020-524-10, OT UltraSmart System Kit; 020-524-10F, OT UltraSmart System Kit;  OT UltraSmart System Kit V. 10 USA; 020-524-10Y, OT UltraSmart System Kit; 020-524-11, System, EAS-C, OUS, US; 020-524-12, System, EAS-S, OUS, US; 020-524-13, OT UltraSmart System; 020-759-02F, OT UltraSmart Meter V.2 USA; 020-759-03F, OT UltraSmart Meter V.3 USA; 020-761-01F, Starter,OUS,US; 020-761-02, OT UltraSmart Starter; 020-761-02F, OT UltraSmart Starter; 020-761-04, OT UltraSmart Starter; 020-761-04F OT UltraSmart Starter; 020-761-05 OT UltraSmart Starter Kit; 020-761-05F, OT UltraSmart Starter Kit; 020-926-01, Dist Kit,SM,OTU,US; 020-930-01, Dist,Kit,OTU/OUS,US; 020-971-01, Disp,Counter,Ultra Kits; 021-075-01, UltraSmart SVP; 021-113-01, Display, Hanging, OUT/OUS, US; 021-133-01, Display, Counter, OTU/OUS Kits; 021-135-01, Span Display, Hanging, OTU, US; and 021-166-01, Display, Hanging, OTU/OUS Kits.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was released for distribution to 40,763 consignees worldwide. The firm provided the following distribution information: 124 wholesaler dealers, 224 distributors, 140 retailers and 40,275 consumers/users involved in the recall. The recall product was distributed in all States within the U.S. In addition, OneTouch UltraSmart meter kits with the affected UltraSmart Owner''s Booklets (AW 060-788-01A) have been distributed internationally in Canada, France, Germany, Italy, United Kingdom, Benelux, Sweden, Finland, Norway, Denmark, Spain, Portugal, Switzerland and Austria. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, and patients who received the recalled products.
  • Product Description
    LifeScan brand One Touch UltraSmart Meter Owners Booklet AW 060-788-01A; || All One Touch UltraSmart Meters shipped with OneTouch UltraSmart Owner''s Booklet AW 060-788-01A are affected by this Field Correction.
  • Manufacturer
    Lifescan Inc

Manufacturer

Lifescan Inc
  • Manufacturer Address
    Lifescan Inc, 1000 Gibraltar Dr, Milpitas CA 95035-6301
  • Source
    USFDA