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

FDA device recall Z-1519-2012 · posted 2012-05-10 · Terminated

Recall details

Recalling firm

Instrumentation Laboratory Co.

Reason for recall

Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GGP

Quantity affected

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, H

Date initiated

2012-04-11

Date posted

2012-05-10

Date terminated

2012-08-24

Location

Bedford, MA

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