FDA Device Recall Z-0007-06: Nichols Institute Diagnostics

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-06.

Recall Res Number

Z-0007-06

Recalling Firm / Manufacturer

Nichols Institute Diagnostics

FEI Number

2050095

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-08-31

Date Posted

2005-10-06

Date Terminated

2012-03-16

Product Code

DHA

Event Number

33412

Product Quantity

174

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

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.

Action Details 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.

Distribution Pattern Nationwide and China, Germany, & Australia

Code Information / Serial Numbers Lot #62-500262

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Medical Device Recall: Z-0007-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer