FDA Device Recall Z-0006-06: Nichols Institute Diagnostics

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0006-06.

Recall Res Number

Z-0006-06

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

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

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#62-500261

Related Establishments / Registrations

SCIENTIFIC SUPPLIES & TECHNOLOGY, INC. Registration: 1036362 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 1319681 View Registration
ABBOTT LABORATORIES Registration: 1415939 View Registration
GERMAINE LABORATORIES, INC. Registration: 1649661 View Registration
MONOBIND, INC. Registration: 2020726 View Registration
CTK BIOTECH, INC. Registration: 2032682 View Registration
EPITOPE DIAGNOSTICS, INC. Registration: 2032839 View Registration
BECKMAN COULTER, INC. Registration: 2122870 View Registration
PRINCETON BIOMEDITECH CORP. Registration: 2246703 View Registration
ORTHO-CLINICAL DIAGNOSTICS, INC. Registration: 2250051 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Ortho-Clinical Diagnostics European Support Center Registration: 3000308930 View Registration
Siemens Healthcare Diagnostics Inc Registration: 3002637618 View Registration
Ortho Clinical Diagnostics Registration: 3002642396 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED Registration: 3002806944 View Registration
ABBOTT GmbH Registration: 3002809144 View Registration
SENSOR HEALTH PRODUCTS, INC. Registration: 3004192065 View Registration
DiaSorin Deutschland GmbH Registration: 3004434309 View Registration
GUANGZHOU WONDFO BIOTECH CO., LTD. Registration: 3004635103 View Registration
ABBOTT IRELAND DIAGNOSTICS DIVISION Registration: 3005094123 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
ABBOTT POINT OF CARE CANADA LIMITED Registration: 3005643513 View Registration
Diamond Diagnostics Inc. Registration: 3006198300 View Registration
THE JAY GROUP Registration: 3006479639 View Registration
Ortho-Clinical Diagnostics Registration: 3007111389 View Registration
WONDFO USA CO., LTD. Registration: 3007606081 View Registration
ABBOTT IRELAND Registration: 3008344661 View Registration
INPECO SA Registration: 3010825766 View Registration
Hangzhou Biotest Biotech Co.,Ltd. Registration: 3011522054 View Registration
Ortho Clinical Diagnostics, K.K. Registration: 3012963943 View Registration
Abbott Laboratories de Mexico Registration: 3016244760 View Registration
ABBOTT LABORATORIES Registration: 3016438761 View Registration
SHENZHEN YHLO BIOTECH CO., LTD. Registration: 3017019647 View Registration
Jay Group Registration: 3017125176 View Registration
Abbott Automation Solutions GmbH Registration: 3023268435 View Registration
GUANGZHOU WONDFO BIOTECH CO., LTD. Registration: 3023322455 View Registration
TOPTOLIFE DIAGNOSTICS LLC Registration: 3042471840 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration
DiaSorin Italia S.p.A. Registration: 9610240 View Registration
Beckman Coulter Ireland Inc Registration: 9680746 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0006-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer