Recall Z-0179-2015— Leica Microsystems, Inc.

Class II FDA medical device recall by Leica Microsystems, Inc., initiated 2014-04-18, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an automated Bond system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.. Reason: Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity..

Recalling firm

Leica Microsystems, Inc.

Classification

Class II

Status

Terminated

Initiated

2014-04-18

Terminated

2017-08-14

Firm location

Buffalo Grove, IL, United States

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