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U.S. Department of Health and Human Services

Class 3 Device Recall Mach 4 Universal HRP Polymer Kit

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  Class 3 Device Recall Mach 4 Universal HRP Polymer Kit see related information
Date Initiated by Firm March 31, 2016
Create Date April 19, 2016
Recall Status1 Terminated 3 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 2		 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.
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