Z-1118-04

Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033

Name: Z-1118-04 Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033
Creator: Nichols Institute Diagnostics
Published: 2004-06-30
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2004-06-30 / Terminated

FDA source

Nichols Institute Diagnostics began a recall of Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033 on 2004-06-30. The reason FDA records is "Lower than expected results are obtained". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1118-04
Status: Terminated
Initiated: 2004-06-30
Posted: 2005-02-24
Terminated: 2012-02-10
Recalling firm: Nichols Institute Diagnostics
Product: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033.
Product code: MRG System, Test, Vitamin D
Reason for recall: Lower than expected results are obtained.
FDA root cause: Other
Action: Firm sent Customer Bulletin No 04-09-AD on June 30, 2004. It addresses the issues and advises customers as to alternative actions, including appending results with a caution statement regarding low recovery.
Quantity in commerce: Not Applicable.
Distribution: Nationwide. Canada, Australia, Greece, Denmark, Portugal, Sweden, Brazil, Italy, japan, Spain, Germany, France.
Product codes and lots: Not limited to specific lots.

Product code MRG

K012367Class IIVitamin D Test System Nichols Advantage 25-Hydroxyvitamin DNichols Institute Diagnostics / cleared 2001-10-09

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)