Z-0007-06

Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)

Name: Z-0007-06 Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
Creator: Nichols Institute Diagnostics
Published: 2005-08-31
License: https://open.fda.gov/license/

Nichols Institute Diagnostics / initiated 2005-08-31 / Terminated

FDA source

Nichols Institute Diagnostics began a recall of Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039) on 2005-08-31. The reason FDA records is "Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0007-06
Status: Terminated
Initiated: 2005-08-31
Posted: 2005-10-06
Terminated: 2012-03-16
Recalling firm: Nichols Institute Diagnostics
Product: Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
Product code: DHA System, Test, Human Chorionic Gonadotropin
Reason for recall: Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
FDA root cause: Other
Action: Withdrawal letter was sent 08/30/2005 which request customers to stop using the product immediately and discard any remaining materials. A response card was included.
Quantity in commerce: 174
Distribution: Nationwide and China, Germany, & Australia
Product codes and lots: Lot #62-500262

Product code DHA

K042676Class IINichols Advantage Hyperglycosylated Human Chorionic Gonadotropin (H-Hcg) AssayNichols Institute Diagnostics / cleared 2004-12-17

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)