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FDA > CDRH > Medical Device Recalls > Class 1 Recall: Counterfeit OneTouch® Ultra® Blood Glucose Test Strips

Class 1 Recall: Counterfeit OneTouch® Ultra® Blood Glucose Test Strips

Date Recall
Initiated:

October 2006
November 2006

Product:

OneTouch® Ultra® blood glucose test strips lot numbers:

  • 2691191
  • 2691261

Characteristics

  • Text on the outer carton and inside container (vial) is printed in multiple languages - English and French.
  • Lot Number is located on the outer carton and on the inside container (vial)
  • Only 50-Count OneTouch® Ultra® Test Strip packages are affected (2 vials of 25 test strips).
  • Counterfeit (fake) packages have no “NDC number” on the bottom of the outer carton.

Use:

 Blood glucose test strips are used by people with diabetes to measure their blood glucose.

Recalling Firm:

Discount Diabetic Supply
1420 N. Lamar, Suite 102
Oxford , Mississippi 38655
( Lot #2691191)

Milwaukee Notions, Inc.
1006 Vine Street
Union Grove , Wisconsin 53182
1-800-558-5090
(Lots #2691191 and #2691261)

Medical Plastics Devices Inc.
161 Oneida Drive
Pointe Claire , Quebec, Canada
( Lot #2691191)

Royal Global Wholesale
5681 Northpoint Lane
Boynton Beach , Florida 33437
(Lots #2691191 and #2691261)

Core Care Technologies, Inc.
309 Fries Mill Rd. , Suite 14
Sewell , New Jersey 08080
(Lots # 2691191 and #2691261)

Matrix Distributors, Inc.
110 Tices Ln
Unit 5B
E Brunswick , New Jersey 08816-2048
( Lot #2691191)

Safety & Supplies Co., Inc.
17 Edgeboro Rd.
East Brunswick, New Jersey 08816-1600
(Lots #2691191 and #2691261)

Reason for Recall:

 These blood glucose test strips are counterfeit (fake) versions
of LifeScan’s products. These counterfeit test strips could give
incorrect blood glucose values, either too high or too low,
which might result in a patient taking either too much or too
little insulin. This could lead to serious injury or death.

Public Contact:

LifeScan Customer Service
Contact: 1-800-227-8862
Email: CustomerService@LifeScan.com

FDA Districts:

New Orleans
Minneapolis
New England
Florida
New Jersey

FDA Comments:

In addition to the device an lot numbers listed in this Class 1 Recall, the following device and lot numbers have also been determined to be counterfeit test strips:

OneTouch® Basic®/Profile® blood glucose test strips lot numbers:

  • 272894A
  • 2619932
  • 2606340
  • 2615211
  • 227078A

Consumers who have the counterfeit test strips should stop using them, replace them immediately and contact their physician.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips – December 15, 2006 http://www.fda.gov/bbs/topics/NEWS/2006/NEW01528.html

LifeScan OneTouch® – Updated December 18, 2006
http://www.lifescan.com/company/about/press/counterfeit/

Updated February 6, 2007

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