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Terminated

Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.

FDA Recall Z-0056-06 · Posted 2005-10-15

Recalling FirmNichols Institute Diagnostics
Recall StatusTerminated
Product CodeCEW
Date Initiated2005-04-14
Date Terminated2012-03-16
Product Quantity323

Reason for Recall

Controls were out of specification range.

Firm Action

Recall letter and response form was sent on April 14, 2005 to all domestic and foreign consignees.

Root Cause

Other

Distribution Pattern

Nationwide, Japan, Spain, Germany and Sweden

Official Source

View FDA Recall →

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

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