FDA Medical Device Recalls (openFDA)
Diagnostic Products Corp: Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
- Recall number
- Z-1015-05
- Recalling firm
- Diagnostic Products Corp
- Product
- Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
- Status
- Terminated
- Initiated
- 2005-05-26
- Posted
- 2005-07-16
- Terminated
- 2006-02-03
- Reason
- Adverse trend in stability, controls biased or out of range.
- Root cause
- Other
- Action
- Recall was initiated by phone using a script, to be followed up with a letter and response form.
- Quantity
- 269
- Distribution
- Nationwide and to Syria, United Kingdom, Puerto Rico, Aruba, Kuwait.
- Lot, serial or model codes
- Lots 302 and 303
- 510(k) numbers
- ["K970877"]
- PMA numbers
- not on file
- Product code
- DHX
- 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