Medical Device Recall: Z-1519-2012

FDA Recalls dataset · Firm: Instrumentation Laboratory Co. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2012-04-11 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-1519-2012.

Recall Res Number
Z-1519-2012
Recalling Firm / Manufacturer
Instrumentation Laboratory Co.
FEI Number
1217183
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2012-04-11
Date Posted
2012-05-10
Date Terminated
2012-08-24
Product Code
GGP
Event Number
61522
Product Quantity
9320 Kits
Product Description Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems
Reason for Recall Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.
Action Details Instrumentation Laboratories mailed Recall Letter via USPS to US and Canadian customers on April 11, 2012, through Beckman Coulter. The customer mailing and tracking of the Urgent Recall Notification and Recovery Procedure in the United States and Canada will be handled through the distributor, Beckman Coulter. Accounts are requested to check inventory for the product lots of Hemosll von Willebrand Factor Activity, PN 0020004700, listed in the table and document their destruction on the provided tracking form and return the completed form. Questions or concerns regarding this notification, please call Beckman Coulter Technical Service at (800) 526-7694. On March 29, an e-mail communication was circulated to the IL Affiliates in Europe and Japan requesting them to translate the Urgent Field Safety Notification [title of document outside US and Canada] and product destruction tracking form, mail the notification to their customer base and notify their Competent Authorities.. Fpr questions regarding this recall call 781-861-4467.
Distribution Pattern Worldwide Distribution - USA (nationwide) and the countries of Canada, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELARUS BELGIUM, BRAZIL, CHILE, CHINA, CZECH REPUBLIC, DENMARK FRANCE, GERMANY, GREECE, HUNGARY, INDIA, IRAN (ISLAMIC REPUBLIC OF), ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF KUWAIT LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS NORWAY, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, and the UNITED ARAB EMIRATES
Code Information / Serial Numbers Lot Numbers:  B01424 Exp Date: March 31 , 2012; B11498 Exp Date: July, 31 , 2012; B11655 Exp Date: November 30, 2012; B11687 Exp Date: January 31 , 2013

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