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Terminated

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

FDA Recall Z-0007-06 · Posted 2005-10-06

Recalling FirmNichols Institute Diagnostics
Recall StatusTerminated
Product CodeDHA
Date Initiated2005-08-31
Date Terminated2012-03-16
Product Quantity174

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042676NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAYNichols Institute Diagnostics · 2004-12-17

Official Source

View FDA Recall →

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

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