Devices

Device Recall Mach 4 Universal HRP Polymer Kit

Model / Serial
Lot number 082715; Expiry 01/2017.
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
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
Product Description
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.
Manufacturer
Biocare Medical, LLC
1 Event
- Recall of Device Recall Mach 4 Universal HRP Polymer Kit

Manufacturer

Biocare Medical, LLC

Manufacturer Address
Biocare Medical, LLC, 4040 Pike Ln, Concord CA 94520-1227
Manufacturer Parent Company (2017)
Biocare Medical LLC
Source
USFDA

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