Recall Z-1523-2016— Biocare Medical, LLC

Class III FDA medical device recall by Biocare Medical, LLC, initiated 2016-03-31, terminated 2016-06-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. 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: Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer..

Recalling firm

Biocare Medical, LLC

Classification

Class III

Status

Terminated

Initiated

2016-03-31

Terminated

2016-06-20

Firm location

Concord, CA, United States

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