Z-1727-2013Class II

B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative...

Name: Z-1727-2013 B-CrossLaps/serum (B-CTx in serum) REF 11972308 160 100 tests Immunoassay for the in vitro quantitative...
Creator: Roche Diagnostics Operations, Inc.
Published: 2013-04-25
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2013-04-25 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2013-04-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1727-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-25
Posted: 2013-07-12
Terminated: 2013-09-27
Recalling firm: Roche Diagnostics GmbH
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.
Product code: JMM Column Chromatography & Color Development, Hydroxyproline
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
Root cause tag: design
FDA root cause: 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.
Product codes and lots: All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1727-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1727-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-12

Product code JMM

K993706Class IElecsys Serum B-Crosslaps/serum ImmunoassayRoche Diagnostics Corp. / cleared 2000-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)