Recall Z-1727-2013 ยท JMM Column Chromatography & Color Development, Hydroxyproline
Roche Diagnostics Operations, Inc.
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 dia
| Date | Jul 12, 2013 (initiated Apr 25, 2013) |
| Status | Terminated |
| Reason | 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 | 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 ( |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993706 | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY Roche Diagnostics Corp., Jul 24, 2000 |