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Terminated

Nichols Advantage ACTH Test System, catalog number 62-7004.

FDA Recall Z-1044-05 · Posted 2005-07-28

Recalling FirmNichols Institute Diagnostics
Recall StatusTerminated
Product CodeCKG
Date Initiated2005-04-22
Date Terminated2012-03-16
Product Quantity1203

Reason for Recall

Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.

Firm Action

Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.

Root Cause

Other

Distribution Pattern

Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K962601NICHOLS ADVANTAGE CHEMILUMINESCENCE ADRENOCORTICOTROPIC HORMONENichols Institute Diagnostics · 1996-12-24

Official Source

View FDA Recall →

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

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