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

FDA device recall Z-1727-2013 · posted 2013-07-12 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

JMM

Quantity affected

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.

Date initiated

2013-04-25

Date posted

2013-07-12

Date terminated

2013-09-27

Location

Indianapolis, IN

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