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Class 2 Device Recall ACL 9000 |
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Date Initiated by Firm |
November 11, 2010 |
Date Posted |
December 27, 2010 |
Recall Status1 |
Terminated 3 on August 23, 2013 |
Recall Number |
Z-0804-2011 |
Recall Event ID |
57274 |
510(K)Number |
K060162
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Product Classification |
Multipurpose System for In Vitro Coagulation Studies - Product Code JPA
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Product |
ACL 9000 Coagulation Analyzer, PN 00000990011
Coagulation testing. |
Code Information |
Serial numbers range 00040105 - 09031882. |
Recalling Firm/ Manufacturer |
Instrumentation Laboratory Co. 180 Hartwell Road Bedford MA 01730-2443
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For Additional Information Contact |
781-861-4467
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Manufacturer Reason for Recall |
Sporadically lowered APTT results were observed with the PT/APTT Test Groups.
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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 |
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 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
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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.
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510(K) Database |
510(K)s with Product Code = JPA and Original Applicant = INSTRUMENTATION LABORATORY CO.
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