Z-1519-2012

Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The...

Name: Z-1519-2012 Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The...
Creator: Instrumentation Laboratory Co.
Published: 2012-04-11
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2012-04-11 / Terminated / root cause: manufacturing process

FDA source

Instrumentation Laboratory Co. began a recall of Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative... on 2012-04-11. The reason FDA records is "Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1519-2012
Status: Terminated
Initiated: 2012-04-11
Posted: 2012-05-10
Terminated: 2012-08-24
Recalling firm: Instrumentation Laboratory Co.
Product: 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
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
Reason for recall: Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 9320 Kits
Distribution: 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
Product codes and lots: 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

Product code GGP

K040843Class IIHemosil Von Willebrand ActivityInstrumentation Laboratory CO / cleared 2004-04-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)