Class 3 Device Recall Mach 4 Universal HRP Polymer Kit

• Date Initiated by Firm: March 31, 2016
• Create Date: April 19, 2016
• Recall Status: Terminated on June 20, 2016
• Recall Number: Z-1523-2016
• Recall Event ID: 73752
• Product Classification: Immunohistochemistry reagents and kits - Product Code NJT
• 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.
• Code Information: Lot number 082715; Expiry 01/2017.
• Recalling Firm/ Manufacturer: Biocare Medical, LLC; 4040 Pike Ln; Concord CA 94520-1227
• For Additional Information Contact: Scott Huntsman; 925-603-8033
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Labeling mix-ups
• Action: Biocare Medical sent a Medical Device Recall Notification letter dated March 31, 2016 to affected US customers by USPS. Foreign consignees were also notified per their various government regulations. The letter identified the affected product, problem and actions to be taken. Customers were requested to complete and return by April 15, 2016 the enclosed Return Response Form.
• Quantity in Commerce: 93
• Distribution: 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
• 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.