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
Roche Diagnostics announced May 18 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.
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