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U.S. Department of Health and Human Services


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Recall -- Firm Press Release


FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.


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


Indianapolis, Ind., May 18, 2009


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 KitsREF NumberLancet CountLancet 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





M25C2, M25C5, M25C7, M32B5, N32A5
ACCU-CHEK® Compact Plus Meter Kit
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.



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