Skip to content

Diagnostic Products Corp.

Also registered as Diagnostic Products Corporation

United StatesFDA applicant, unverified

Devices
324
FDA recalls
7

What Diagnostic Products Corp. makes

Diagnostic Products Corp. manufactures in vitro diagnostic assays for hormone and biomarker measurement, including radioimmunoassays (RIAs), enzyme immunoassays (EIAs), and immunoassays for thyroid hormones (e.g., thyroxine), cardiac markers (e.g., CK-MB), and reproductive hormones (e.g., progesterone, prolactin, androstenedione). Their portfolio also includes kits for digoxin and digitoxin detection, as well as controls and components for human chorionic gonadotropin (HCG) testing.

The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions recorded via the 510(k) pathway. Products are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue324

Newest first, rows 51-100 of 324

Search and filter all 324 devices
Skip device list

Rows 51-100 of 324

Showing 51-100 of 324

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 7 recalls initiated by Diagnostic Products Corp., the earliest on 2003-07-31 and the most recent on 2006-01-03. By recorded status: 7 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2006

    • 3 Jan 2006 Z-0528-06 Unclassified (pre-2012) Terminated The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration. Distribution: Nationwide and Worldwide in Pakistan, Italy, Cyprus, Turkey, Switzerland, Chile, South Africa, Greece, Mexica, Canada,…
      Full distribution text Nationwide and Worldwide in Pakistan, Italy, Cyprus, Turkey, Switzerland, Chile, South Africa, Greece, Mexica, Canada, Thialand, Germany, India, United Arab Emirates, Hungary, Israel, Portugal, Taiwan, Austria, Saudi Arabia, Malaysia, Hong Kong, India, Colombia, Argentina, Australia, Costa Rica, Czech Republic, Spain, France, Panama, Brazil, Netherlands, Poland, Sweden, United Kingdom, & El Salvadon.
      Submission number: K032881

  • 2005

    • 26 May 2005 Z-1015-05 Unclassified (pre-2012) Terminated Adverse trend in stability, controls biased or out of range. Distribution: Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait. Submission number: K970877
    • 24 Jan 2005 Z-0537-05 Unclassified (pre-2012) Terminated A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only. Distribution: AL, CA, CO, FL, IL, KS, LA, NY, MA, MD, MI, MS, NC, NE, NM, OH, PA, TN, TX, UT, WA, and Australia, Czech Republic,…
      Full distribution text AL, CA, CO, FL, IL, KS, LA, NY, MA, MD, MI, MS, NC, NE, NM, OH, PA, TN, TX, UT, WA, and Australia, Czech Republic, France, Germany, Netherlands, Portugal, Puerto Rico, Sweden, Turkey, UK, Venzuela
      Submission number: K993251

  • 2004

    • 19 Nov 2004 Z-0324-05 Unclassified (pre-2012) Terminated Low bias of 10 to 40% at different levels of insulin in samples. Distribution: Medical facilities in AK, NY, WI.
    • 3 May 2004 Z-0972-04 Unclassified (pre-2012) Terminated Instabililty Submission number: K970877
    • 23 Feb 2004 Z-0724-04 Unclassified (pre-2012) Terminated High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA. Distribution: North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital,…
      Full distribution text North America, Central America, South America, Europe, Asia, South Africa, Middle East. Domestic includes: VA Hospital, St. Louis MO VA Medical Center, Denver, CO VA Medical Center, Richmond, VA VA Medical Center, West Haven, CT Walter Reed Army Medical Center, Washington DC
      Submission number: K013566

  • 2003

    • 31 Jul 2003 Z-1219-03 Unclassified (pre-2012) Terminated Kits had parts in them that did not belong in the kit. Distribution: US, Italy, Turkey, Czech Republic, Poland, Sweden, Canada, Germany and Austria Submission number: K000463