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Terminated

Immulite 1000 CEA Catalog No. LKCE1

FDA Recall Z-0972-04 · Posted 2004-07-20

Recall StatusTerminated
Product CodeDHX
Date Initiated2004-05-03
Date Terminated2004-07-01
Product Quantity884

Reason for Recall

Instabililty

Firm Action

Notice was made via email or telephone. Users are to discard kits.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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