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U.S. Department of Health and Human Services

Class 2 Device Recall ELECSYS CrossLaps/Serum Immunoassay

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  Class 2 Device Recall ELECSYS CrossLaps/Serum Immunoassay see related information
Date Initiated by Firm April 25, 2013
Date Posted July 12, 2013
Recall Status1 Terminated 3 on September 27, 2013
Recall Number Z-1727-2013
Recall Event ID 65163
510(K)Number K993706  
Product Classification Column chromatography & color development, hydroxyproline - Product Code JMM
Product 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.
Code Information All lot numbers
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Todd Siesky
317-521-3911
Manufacturer 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 ¿-CrossLaps (¿-CL) assay package insert version 5, could not be reproduced. The ¿-CrossLaps test results contribute to the monitoring of antiresorptive therapy. False low or false normal results may lead to delayed diagnosis and treatment of osteoporosi
FDA Determined
Cause 2		 Device Design
Action The firm, Roche, sent an "URGENT MEDICAL DEVICE CORRECTION" (UMDC)letter dated May 2, 2013, to its consignees/customers via UPS Ground. The letter describes the product, problem and actions to be taken. The consignees/customers were instructed to apply the correct sample storage conditions as stated in the UMDC and to inform all relevant parties about the correct biotin interference claim. The consignees/customers were instructed to keep the UMDC on file for reference until the revised package insert is available. The consignees/customers were asked to complete and return a form via fax (1-888-943-4205). Consignees/customers were instructed to call Roche Diagnostics Technical Support, 24 hours a day, seven days a week, at 1-800-428-2336 if they had any questions about the recall. Non-responding accounts are monitored on an ongoing basis.
Quantity in Commerce 3056 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JMM and Original Applicant = ROCHE DIAGNOSTICS CORP.
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