Roche Diagnostics notifies customers of the potential for ACCU-CHEKÂ Softclix 10 and/or 17 count lancets to be uncapped which may lead to an accidental needle stick

Date of Recall

2009-05-17

Recall Details

Roche Diagnostics announced today that it is notifying its customers and healthcare professionals about a potential issue with a small number of ACCUCHEK ® Softclix 10 and/or 17 count lancets that have missing caps that were distributed as samples or in the following meter kits:

Meter Kits	REF Number	Lancet Count	Lancet Lot Numbers Affected
ACCU-CHEK® Active Meter Kit ACCU-CHEK® Voicemate Meter ACCU-CHEK® Aviva Meter kits that include an ACCU-CHEK® Softclix lancing device Coaguchek XS Systems for Patient Self-Testing	03184501001 12030802001 04893247001 04837738001	10	M25C2, M25C5, M25C7, M32B5, N32A5
ACCU-CHEK® Compact Plus Meter Kit	03149137001, 05177294001, 05079241001	17	M25C9, M25D2, M27D6, M32A8, M32B3

 

Missing caps can lead to the potential for an accidental needle stick. It is for this reason that Roche Diagnostics, in cooperation with the U.S. Food and Drug Administration (FDA), is voluntarily requesting that customers inspect their lancets prior to opening the plastic bag containing the lancets. If customers notice ACCU-CHEK Softclix 10 and/or 17 count lancets without caps do not
use them. Additionally, customers should use caution while handling the lancets to avoid the potential for an accidental needle stick, dispose of them in apuncture proof container with a lid, and contact one of the following phone numbers for a replacement:

• Diabetes Care customers: 1-800-778-7057 (ACCU-CHEK Customer Care Service Center)
• CoaguChek customers: 1-800-778-7505 (Point-of-Care Technical Service) Customers should always use caution when handling lancets. Roche takes this issue very seriously and is taking steps to prevent this issue in the future.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R & D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information refer to: www.roche-diagnostics.us, www.poc.roche.com, or www.Accu-chek.com.

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