FDA Medical Device Recalls (openFDA)
Diagnostic Products Corp: IMMULITE 2000 Intact PTH kit
- Recall number
- Z-0724-04
- Recalling firm
- Diagnostic Products Corp
- Product
- IMMULITE 2000 Intact PTH kit
- Status
- Terminated
- Initiated
- 2004-02-23
- Posted
- 2004-07-20
- Terminated
- 2004-12-02
- Reason
- High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.
- Root cause
- Other
- Action
- Recall was by letter mailed / faxed on February 23, 2004. Users are instructed to remove EDTA plasma samples for consideration for testing and correct instructions in the package insert.
- Quantity
- 2416 kits
- Distribution
- 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
- Lot, serial or model codes
- Kit lots L2KPP 117 (exp date Aug 31 2004) and 118 (exp date Oct 31 2004)
- 510(k) numbers
- ["K013566"]
- PMA numbers
- not on file
- Product code
- CEW
- Firm FEI
- 3005250747
- Firm city
- Los Angeles
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28