Class 2 Device Recall IDS Urine BETA CrossLaps ELISA

• Date Initiated by Firm: August 10, 2012
• Date Posted: October 10, 2012
• Recall Status: Terminated on December 17, 2012
• Recall Number: Z-0039-2013
• Recall Event ID: 62968
• Product Classification: N/A - Product Code JMM
• Product: IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles.; ; The Urine BETA CrossLaps¿ ELISA is an enzyme immunological test for the quantification of degradation products of C-terminal telopeptides of Type-I collagen in human urine. The Urine BETA CrossLaps¿ ELISA assay is intended for in vitro diagnostic use as an indication of human bone resorption as an aid in A. Monitoring bone resorption changes of 1) Anti-resorptive therapies in postmenopausal women: a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies B. Predicting skeletal response (Bone Mineral Density) in postmenopausal women undergoing anti-resorptive therapies a) Hormone Replacement Therapies (HRT) with hormones and hormone like drugs b) Bisphosphonate therapies
• Code Information: Lot 14541, EXP Nov 2012
• Recalling Firm/ Manufacturer: Immunodiagnostics Systems Ltd; 10 Didcot Way Bolden Business Park; Boldon Tyne & Wear United Kingdom
• Manufacturer Reason for Recall: It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.
• FDA Determined Cause: Labeling False and Misleading
• Action: Immunodiagnostics Systems sent Customer notification letters via email and notified customers of the recall. The notification included the reason for recall, product information with codes, lot number, manufacturing/distribution date, and exp date. The notification included instructions to customers: Actions to be taken by the customer: Customers should complete the attached Recall and Acknowledgement Form and take the following actions: 1) Check your stock for the products included within the scope of the recall. Cease use and distribution and quarantine all affected product lots immediately. 2) Complete the enclosed Recall & Acknowledgement Form and immediately fax back to Immunodiagnostic Systems. This will allow us to document your receipt of this letter and the amount of product you have on hand for return. 3) Return any affected product freight collect, along with the original completed Recall & Acknowledgement Form to your local IDS office. Contact information was also provided. For questions regarding this recall call +44 (191) 5195212.
• Quantity in Commerce: 1
• Distribution: Nationwide Distribution including NY, CA, ME and CT.
• 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.