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Terminated

IMMULITE 2000 Intact PTH kit

FDA Recall Z-0724-04 · Posted 2004-07-20

Recalling FirmDiagnostic Products Corp
Recall StatusTerminated
Product CodeCEW
Date Initiated2004-02-23
Date Terminated2004-12-02
Product Quantity2416 kits

Reason for Recall

High bias noted in samples collected with EDTA. Indication is to not run samples with EDTA.

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013566IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6Diagnostic Products Corp. · 2001-11-20

Official Source

View FDA Recall →

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

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