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FDA Medical Device Recalls (openFDA)

Diagnostic Products Corp: Immulite 1000 CEA Catalog No. LKCE1

Recall number
Z-0972-04
Recalling firm
Diagnostic Products Corp
Product
Immulite 1000 CEA Catalog No. LKCE1
Status
Terminated
Initiated
2004-05-03
Posted
2004-07-20
Terminated
2004-07-01
Reason
Instabililty
Root cause
Other
Action
Notice was made via email or telephone. Users are to discard kits.
Quantity
884
Distribution
not on file
Lot, serial or model codes
Lots 5 157 and 5 157L
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

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