Z-0809-05

Nichols IRMA Intact PTH Assay, catalog No. 40-2171

Name: Z-0809-05 Nichols IRMA Intact PTH Assay, catalog No. 40-2171
Creator: Nichols Institute Diagnostics
Published: 2005-03-25
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2005-03-25 / Terminated / root cause: labeling and UDI

FDA source

Nichols Institute Diagnostics began a recall of Nichols IRMA Intact PTH Assay, catalog No. 40-2171 on 2005-03-25. The reason FDA records is "Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0809-05
Status: Terminated
Initiated: 2005-03-25
Posted: 2005-05-10
Terminated: 2012-03-16
Recalling firm: Nichols Institute Diagnostics
Product: Nichols IRMA Intact PTH Assay, catalog No. 40-2171
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm sent customer notifications to firms on March 9 and 11, 2005 which were deemed not appropriate upon review by the FDA, firm agreed to resend notices approved by FDA on March 25, 2005 which requested that customers cease using the lots and destroy inventory for credit.
Quantity in commerce: Not divulged
Distribution: Nationwide, Canada, Greece, Italy, Sweden, Austria, Balgium, Korea, Spain, Grea Britian, Taiwan, Finland, Denmark, New Zealand, Israel
Product codes and lots: Lots 40-504553/4 released March 4, 2005 and kit lots 40-501687/8 released March 18, 2005

Product code CEW

K861797Class IIAllegro Intact Parathyroid Hormone ImmunoassayNichols Institute Diagnostics / cleared 1986-07-22

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)