Z-0056-06

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

Name: Z-0056-06 Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045
Creator: Nichols Institute Diagnostics
Published: 2005-04-14
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2005-04-14 / Terminated

FDA source

Nichols Institute Diagnostics began a recall of Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045 on 2005-04-14. The reason FDA records is "Controls were out of specification range". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0056-06
Status: Terminated
Initiated: 2005-04-14
Posted: 2005-10-15
Terminated: 2012-03-16
Recalling firm: Nichols Institute Diagnostics
Product: Nichols Advantage QuiCk- Intraoperative Bio-Intact PTH Assay, Catalog No. 62-7045.
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: Controls were out of specification range.
FDA root cause: Other
Action: Recall letter and response form was sent on April 14, 2005 to all domestic and foreign consignees.
Quantity in commerce: 323
Distribution: Nationwide, Japan, Spain, Germany and Sweden
Product codes and lots: Lot 62-402651

Product code CEW

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)