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.
Hazard
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.
What You Should Do
Remedy
On 6/9/05, the firm initiated the recall and their notification was via letters informing its customers of the corrective action.
Affected by this recall?
Get a free legal consultation about this recall.
Talk to a Lawyer →Affiliate link
Products
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 Co
- Brand
- Lifescan Inc
- UPC
- 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.
Units Affected
584,291 units