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U.S. Department of Health and Human Services

Enforcement Report - Week of April 24, 2013

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Product Detail

Product Description ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).
Recall Number Z-1113-2013
Classification Class II
Code Info part number 05060311001, 05060303001
Product Distributed Qty Both devices 4467
Reason For Recall Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards.

Event Detail

Event Id 64460
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 2013-03-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.