Recall Z-0039-2013— Immunodiagnostics Systems Ltd

Class II FDA medical device recall by Immunodiagnostics Systems Ltd, initiated 2012-08-10, terminated 2012-12-17. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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..

Recalling firm

Immunodiagnostics Systems Ltd

Classification

Class II

Status

Terminated

Initiated

2012-08-10

Terminated

2012-12-17

Firm location

Boldon Tyne & Wear, N/A, United Kingdom

Data sourced from openFDA. This site is unofficial and independent of the FDA.