FDA Device Recall Z-0736-2016: Instrumentation Laboratory Co.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0736-2016.

Recall Res Number

Z-0736-2016

Recalling Firm / Manufacturer

Instrumentation Laboratory Co.

FEI Number

1217183

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2015-12-18

Date Posted

2016-02-01

Date Terminated

2017-08-30

Product Code

GGP

Event Number

72972

Product Quantity

Domestic: 108 kits, Foreign: 197 kits

Product Description HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate

Reason for Recall This Lot is not meeting labeled on-board instrument stability claims of 5 days.

Action Details Instrumentation Laboratory Co. sent an " Urgent Medical Device Removal" letter dated December 2015, was sent on December 18, 2015. via USPS to US and Canadian customers. The notification requires US and Canadian customers to respond using a Mandatory Response Tracking Form. A Field Safety Notice was e-mailed on December 18, 2015, to the affected IL affiliates, notifying them of the product lot removal due to a stability issue and requesting them to translate the Field Safety Notice, to notify their Competent Authorities and to provide the notification to their affected customer base and secondary distributors. For further questions, please call 1(800) 955-9525.

Distribution Pattern Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.

Code Information / Serial Numbers Lot No. N0455811, Expiration Date 03/31/2017

Related Establishments / Registrations

INSTRUMENTATION LABORATORY CO. Registration: 1217183 View Registration
HELENA LABORATORIES, CORP. Registration: 1618982 View Registration
CORGENIX, INC. Registration: 1721937 View Registration
R2 DIAGNOSTICS, INC. Registration: 1835316 View Registration
Immucor GTI Diagnostics, Inc. Registration: 2183608 View Registration
DIAGNOSTICA STAGO, INC. Registration: 2245451 View Registration
INSTRUMENTATION LABORATORY CO. Registration: 2431530 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
CHRONO-LOG CORP. Registration: 2518152 View Registration
AFFINITY BIOLOGICALS INC. Registration: 3003485232 View Registration
BIT Analytical Solutions GmbH Registration: 3003601075 View Registration
BIOMEDICA DIAGNOSTICS INC. Registration: 3003691680 View Registration
ROSSIX AB Registration: 3004075036 View Registration
HYPHEN BIOMED SASU Registration: 3004434070 View Registration
DSRV, INC. Registration: 3004737529 View Registration
TCOAG IRELAND LIMITED Registration: 3008386529 View Registration
INSTRUMENTATION LABORATORY CO. - Devens Registration: 3037000637 View Registration
Precision BioLogic Inc. Registration: 8043599 View Registration
BIOKIT S.A. Registration: 9610746 View Registration
Siemens Healthcare Diagnostics Products GmbH Registration: 9610806 View Registration
Diagnostica Stago - Taverny Registration: 9710666 View Registration

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Medical Device Recall: Z-0736-2016

Recall Parameters & Description

Related Establishments / Registrations

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