Z-1044-05

Nichols Advantage ACTH Test System, catalog number 62-7004

Name: Z-1044-05 Nichols Advantage ACTH Test System, catalog number 62-7004
Creator: Nichols Institute Diagnostics
Published: 2005-04-22
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2005-04-22 / Terminated

FDA source

Nichols Institute Diagnostics began a recall of Nichols Advantage ACTH Test System, catalog number 62-7004 on 2005-04-22. The reason FDA records is "Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1044-05
Status: Terminated
Initiated: 2005-04-22
Posted: 2005-07-28
Terminated: 2012-03-16
Recalling firm: Nichols Institute Diagnostics
Product: Nichols Advantage ACTH Test System, catalog number 62-7004.
Product code: CKG Radioimmunoassay, Acth
Reason for recall: Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay.
FDA root cause: Other
Action: Firm send letters to Lab Directors on April 22 and 29th, 2005 requesting destruction of product for credit.
Quantity in commerce: 1203
Distribution: Nationwide and Hungary, Poland, Australia, Canada, Germany, Greece, Italy, Spain, Sweden
Product codes and lots: Lot 62-500040 and 62-404296

Product code CKG

K962601Class IINichols Advantage Chemiluminescence Adrenocorticotropic HormoneNichols Institute Diagnostics / cleared 1996-12-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)