ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.

FDA device recall Z-0804-2011 · posted 2010-12-27 · Terminated

Recall details

Recalling firm

Instrumentation Laboratory Co.

Reason for recall

Sporadically lowered APTT results were observed with the PT/APTT Test Groups.

Action taken

On 11/11/10, An Urgent Product Notification informing customers to discontinue use of all IL locked PT/APTT-based Test Groups was mailed to U.S. and Canadian customers, instructing them to run in Single Test or Profile Mode until further notice. The letter identified the affected product, the issue, risk and stated a list of mandatory actions. Customers are to immediately acknowledge the receipt of the notification by signing and returning it via email or fax. A Worldwide Regulatory Notice was sent on November 8, 2010 to international affiliates (non-U.S. or Canada), notifying them of the issue, providing a risk summary and the support documentation for the notification. Secondary international dealers were notified Nov 8 and a fax response of notification of the dealers will be tracked by International Laboratories. The customer notification of the secondary dealers will be handled per the local regulatory requirements of the countries where they are located.

Root cause

Device Design

Status

Terminated

Product code

JPA

Quantity affected

87 distributed in USA & Canada

Distribution

Worldwide Distribution -- USA, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United

Date initiated

2010-11-11

Date posted

2010-12-27

Date terminated

2013-08-23

Location

Bedford, MA

Related 510(k) clearances