Medical Device Recall: Z-0806-2011

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

Recall Action Class: N/A Date Initiated: 2010-11-11 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0806-2011.

Recall Res Number
Z-0806-2011
Recalling Firm / Manufacturer
Instrumentation Laboratory Co.
FEI Number
1217183
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-11-11
Date Posted
2010-12-27
Date Terminated
2013-08-23
Product Code
JPA
Event Number
57274
Product Quantity
514 distributed in USA & Canada, 55 in distribution channel subject to recall
Product Description ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.
Reason for Recall Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
Action Details 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.
Distribution Pattern Worldwide Distribution -- USA, Canada, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turkmenistan, United Arabian Emirates, Uruguay, Venezuela, Vietnam, Austria, Belgium, China, France, Germany, Holland, Italy, Japan, Spain (and Portugal), and UK.
Code Information / Serial Numbers Serial numbers range 05010100 - 10111176.

Related Establishments / Registrations

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