Devices

Device Recall TREPCHEK

  • Model / Serial
    Lot Number 71303, expiration date June 2004
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to three hospitals/clinics in AZ, CA and TX.
  • Product Description
    Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127
  • Manufacturer
    Diamedix Corporation
  • 1 Event

Manufacturer

Diamedix Corporation
  • Manufacturer Address
    Diamedix Corporation, 2140 N Miami Ave, Miami FL 33127-4916
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Device Recall TrepChek Syphilis Test Kit
  • Model / Serial
    lot # 041207T expiration date 9-30-2005
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA, CA, TX, KS, NY, FL
  • Product Description
    Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2.
  • Manufacturer
    Diasorin Inc.