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Terminated

Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040

FDA Recall Z-0810-05 · Posted 2005-05-10

Recalling FirmNichols Institute Diagnostics
Recall StatusTerminated
Product CodeCEW
Date Initiated2005-04-07
Date Terminated2012-03-16
Product Quantity13751

Reason for Recall

Values do not agree with Directional Instructions.

Firm Action

Firm sent separate notices for each lot of product to customers dated March 25, 2005 requesting destruction of remaining product and affirmation of that activity via a response form. Users were also provided detailed listing of performance characteristics related to the deficiencies for thier information and evaluation per thier own lab''s SOP''s.

Root Cause

Other

Distribution Pattern

Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033727NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAYNichols Institute Diagnostics · 2004-04-22

Official Source

View FDA Recall →

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

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