Z-0874-05

Nichols Advantage TSH - Third Generation

Name: Z-0874-05 Nichols Advantage TSH - Third Generation
Creator: Nichols Institute Diagnostics
Published: 2005-04-28
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2005-04-28 / Terminated / root cause: labeling and UDI

FDA source

Nichols Institute Diagnostics began a recall of Nichols Advantage TSH - Third Generation on 2005-04-28. The reason FDA records is "Does not meet performance claims in 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-0874-05
Status: Terminated
Initiated: 2005-04-28
Posted: 2015-06-25
Terminated: 2012-03-16
Recalling firm: Nichols Institute Diagnostics
Product: Nichols Advantage TSH - Third Generation
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Does not meet performance claims in the labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm sent recall letter and response form April 28, 2005. Firm will follow-up to nonrespondants.
Quantity in commerce: 1072
Distribution: Nationwide, Germany, Greece and Spain
Product codes and lots: Lots 62-400791 and 62-400796

Product code JLW

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)