Z-0810-05

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

Name: Z-0810-05 Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
Creator: Nichols Institute Diagnostics
Published: 2005-04-07
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2005-04-07 / Terminated

FDA source

Nichols Institute Diagnostics began a recall of Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040 on 2005-04-07. The reason FDA records is "Values do not agree with Directional Instructions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0810-05
Status: Terminated
Initiated: 2005-04-07
Posted: 2005-05-10
Terminated: 2012-03-16
Recalling firm: Nichols Institute Diagnostics
Product: Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: Values do not agree with Directional Instructions.
FDA root cause: Other
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.
Quantity in commerce: 13751
Distribution: Nationwide and to Australia, Canada, Chile, France, Germany, Greece, Italy, japan, Spain, Sweden
Product codes and lots: Lots 62-402598 and 62-402622

Product code CEW

K033727Class IINichols Advantage Bio-Intact Pth (1-84) ImmunoassayNichols Institute Diagnostics / cleared 2004-04-22

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)