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

Class 1 Recall: Counterfeit OneTouch® Basic®/Profile® Blood Glucose Test Strips

Date Recall
Initiated:

October 2006
November 2006

Product:

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

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

Lot # 2606340, 2619932 or 272894A Characteristics

  • Text on the outer carton is printed in multiple Languages: English, Greek and Portuguese.
  • Lot Number is located on the outer carton and on the inside container (vial)
  • Only 50-Count OneTouch® (Basic®/Profile®) 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.

Lot # 227078A or 2615211 Characteristics

  • Text on the outer carton and inside container (vial) is printed in English.
  • Lot Number is located on the outer carton and on the inside container (vial)
  • Only 50-Count OneTouch® (Basic®/Profile®) Test Strip packages are affected (2 vials of 25 test strips).
  • The counterfeit (fake) test strips are labeled as “plasma-calibrated” on the inside container (vertical text on side of vial).
  • A picture of a hand on the test strip appears on the outer carton.
  • Counterfeit 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:

Medishop Inc.
6 Bay Street , 4th Floor
Brooklyn , New York 11231-1906
(Lots #272894A, #2606340 and #2619932)

Medical Plastics Devices Inc.
161 Oneida Drive
Pointe Claire, Quebec
(Lots #2619932 and #2606340)

Milwaukee Notions, Inc.
1006 Vine Street
Union Grove, Wisconsin 53182
( Lot #2615211)

Core Care Technologies, Inc.
309 Fries Mill Rd., Suite 14
Sewell, New Jersey 08080
(Lots #272894A, #2619932, #2606340 and #2615211)

Royal Global Wholesale
5681 Northpoint Lane
Boynton Beach, Florida 33437
(Lots #272894A, #2619932, #2606340 and #2615211)

Safety & Supplies Co., Inc.
17 Edgeboro Rd.
East Brunswick, New Jersey 08816-1600
(Lots #272894A, #2619932, #2606340, #227078A and #2615211)

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 York Downstate
New England
Minneapolis
New Jersey
Florida District

FDA Comments:

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

  • OneTouch® Ultra® blood glucose test strips lots #2691191 and #2691261

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 March 9, 2007

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