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Terminated

Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.

FDA Recall Z-1118-04 · Posted 2005-02-24

Recalling FirmNichols Institute Diagnostics
Recall StatusTerminated
Product CodeMRG
Date Initiated2004-06-30
Date Terminated2012-02-10
Product QuantityNot Applicable.

Reason for Recall

Lower than expected results are obtained.

Firm Action

Firm sent Customer Bulletin No 04-09-AD on June 30, 2004. It addresses the issues and advises customers as to alternative actions, including appending results with a caution statement regarding low recovery.

Root Cause

Other

Distribution Pattern

Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012367VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN DNichols Institute Diagnostics · 2001-10-09

Official Source

View FDA Recall →

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

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