FDA Device

Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303

Hazard

Adverse trend in stability, controls biased or out of range.

What You Should Do

Remedy

Recall was initiated by phone using a script, to be followed up with a letter and response form.

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Products

Immulite/ Immulite 1000 Carcinoembryonic Antigen (CEA) LKCE1 lot 302 and 303
Brand
Diagnostic Products Corp
UPC
Lots 302 and 303

Units Affected

269

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