Diagnostic Products Corp.
United StatesFDA 510(k) applicant, unverified
- Devices
- 324
- FDA recalls
- 7
At a glance
Market reach
- United States
- FDA recalls
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.
Catalogue
Search and filter all 324 devicesShowing 1-50 of 324
FDA recalls
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.
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.
Full distribution text
- 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.
2005
- 26 May 2005 Z-1015-05 Unclassified (pre-2012) Terminated Adverse trend in stability, controls biased or out of range.
- 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.
Full distribution text
2004
- 19 Nov 2004 Z-0324-05 Unclassified (pre-2012) Terminated Low bias of 10 to 40% at different levels of insulin in samples.
- 3 May 2004 Z-0972-04 Unclassified (pre-2012) Terminated Instabililty
- 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.
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2003
- 31 Jul 2003 Z-1219-03 Unclassified (pre-2012) Terminated Kits had parts in them that did not belong in the kit.
Frequently asked questions
How many devices does Diagnostic Products Corp. have in the registry?
The registry currently lists 324 devices for Diagnostic Products Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnostic Products Corp.'s devices?
Among its 50 most recently registered devices, Diagnostic Products Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Diagnostic Products Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Diagnostic Products Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Diagnostic Products Corp.?
FDA recall records list 7 recalls initiated by Diagnostic Products Corp., the most recent initiated on 2006-01-03. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Diagnostic Products Corp. in the registry?
The most recently registered devices listed for Diagnostic Products Corp. include IMMULITE 2000 3RD GENERATION PSA, IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5, COAT-A-COUNT T4 RIA KIT and IMMULITE(R) TBG.