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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative determination of degradation products of type I collagen in human serum and plasma as an aid in assessing bone resorption. The test may be used as an aid in monitoring antiresorptive therapies (e.g. bisphosphonates, hormone replacement therapy - HRT) in postmenopausal women and individuals diagnosed with osteopenia. The electrochemiluminescence immunoassay ECLIA is intended for use on Elecsys and cobas e immunoassay analyzers.
Recall Number Z-1727-2013
Classification Class II
Code Info All lot numbers
Product Distributed Qty 3056 units
Reason For Recall Roche Diagnostics internal investigations in R&D have shown that the claims for biotin interference and the sample stability given in the Elecsys ß-CrossLaps (ß-CL) assay package insert version 5, could not be reproduced. The ß-CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosis in the short term. To date, no customer complaints have been reported.

Event Detail

Event Id 65163
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 2013-04-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide distribution: USA including states of: AL, CA, GA, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, TX, VA, VT, and WA.
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