Recall Z-1519-2012 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
Instrumentation Laboratory Co.
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
| Date | May 10, 2012 (initiated Apr 11, 2012) |
| Status | Terminated |
| Reason | Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay. |
| 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, |
| Quantity | 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 L |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040843 | HEMOSIL VON WILLEBRAND ACTIVITY Instrumentation Laboratory CO, Apr 30, 2004 |