Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit recalled over labeling errors

Recall date

March 31, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Biocare Medical, LLC recalls Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunolog…

Recall number

Z-1523-2016

FDA classification

Class III

Brand / firm

Biocare Medical, LLC

Sold / distributed

US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR. Hungary, Canada, Boliva

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.