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U.S. Department of Health and Human Services

Class 2 Device Recall ACL ELITE

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  Class 2 Device Recall ACL ELITE see related information
Date Initiated by Firm November 11, 2010
Date Posted December 27, 2010
Recall Status1 Terminated 3 on August 23, 2013
Recall Number Z-0806-2011
Recall Event ID 57274
510(K)Number K060162  
Product Classification Multipurpose System for In Vitro Coagulation Studies - Product Code JPA
Product ACL ELITE Coagulation Analyzer, PN 00000880311

Coagulation testing.
Code Information Serial numbers range 05010100 - 10111176.
Recalling Firm/
Manufacturer		 Instrumentation Laboratory Co.
180 Hartwell Road
Bedford MA 01730-2443
For Additional Information Contact
781-861-4467
Manufacturer Reason
for Recall		 Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 514 distributed in USA & Canada, 55 in distribution channel subject to recall
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JPA and Original Applicant = INSTRUMENTATION LABORATORY CO.
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