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U.S. Department of Health and Human Services

Enforcement Report - Week of September 4, 2013

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Product Detail

Product Description ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction with a blood glucose monitoring system.
Recall Number Z-2109-2013
Classification Class II
Code Info Lot Number(s): GDA 048, GDA050, GDA 051, GDA 063
Product Distributed Qty 36,332
Reason For Recall Internal Roche inspections have revealed that after the lancet is used for a finger stick, the needle may not fully retract back within the lancet drum or back into the cap. This allows the needle to protrude inside the cap or outside of the cap of the ACCU-CHEK FastClix lancing device.

Event Detail

Event Id 65886
Product Type Devices
Status Ongoing
Recalling Firm Roche Diagnostics Operations, Inc.
City Indianapolis
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution