Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)

FDA Recall Z-0006-06 · Posted 2005-10-06

Recalling FirmNichols Institute Diagnostics
Recall StatusTerminated
Product CodeDHA
Date Initiated2005-08-31
Date Terminated2012-03-16
Product Quantity22

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and China, Germany, & Australia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑