FDA Device Recall Z-0034-2008: Louisville Apl Diagnostics Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0034-2008.

Recall Res Number

Z-0034-2008

Recalling Firm / Manufacturer

Louisville Apl Diagnostics Inc

FEI Number

1000305932

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-07-18

Date Posted

2007-10-04

Date Terminated

2007-10-24

Product Code

MID

Event Number

39412

Product Quantity

3 test kits (each kit containing 1 IgG and 1 IgM test kit)

Product Description APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).

Reason for Recall Product mislabeled; outer container labeled with incorrect lot number.

Action Details Firm sent replacement labels to consignee via FedEx on 07/18/06 with instructions for consignee to change the labels on the kit boxes before shipping kits to end users.

Distribution Pattern Product was shipped to a distributor in Canada.

Code Information / Serial Numbers Lot #060425. Lot number on the outer packaging of the received kits was 060308.

Related Establishments / Registrations

HEMAGEN DIAGNOSTICS, INC. Registration: 1181055 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
American Laboratory Products Company Registration: 1222302 View Registration
THERATEST LABORATORIES, INC. Registration: 1421346 View Registration
LOUISVILLE APL DIAGNOSTICS, INC. Registration: 1529254 View Registration
CORGENIX, INC. Registration: 1721937 View Registration
TECO DIAGNOSTICS Registration: 1832216 View Registration
INOVA DIAGNOSTICS, INC. Registration: 2026994 View Registration
Diagnostic Automation/ Cortez Diagnostics Inc,. Registration: 2029372 View Registration
ZEUS SCIENTIFIC LLC Registration: 2242436 View Registration
DRG International, Inc. Registration: 2245285 View Registration
Bio-Rad Laboratories, Inc. Registration: 2915274 View Registration
IMMUNO CONCEPTS, NA, Ltd. Registration: 2918768 View Registration
DRG INSTRUMENTS GMBH Registration: 3002800697 View Registration
AESKU.DIAGNOSTICS GmbH&Co.KG Registration: 3003825930 View Registration
PHADIA US INC. Registration: 3004973408 View Registration
INSTRUMENTATION LABORATORY SPA Registration: 3012348571 View Registration
IMMUNOCENTRIX CORPORATION Registration: 3022178699 View Registration
BIO-RAD LABORATORIES, INC. Registration: 3032705 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
PHADIA AB Registration: 3039353646 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
PHADIA AB Registration: 9610566 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
PHADIA GMBH Registration: 9680745 View Registration

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Medical Device Recall: Z-0034-2008

Recall Parameters & Description

Related Establishments / Registrations

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