Class 2 Device Recall Instumentation Laboratory

• Date Initiated by Firm: May 19, 2005
• Date Posted: June 21, 2005
• Recall Status: Terminated on December 06, 2006
• Recall Number: Z-0915-05
• Recall Event ID: 32155
• 510(K)Number: K002400 K033414 K951891
• Product Classification: System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
• Product: ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPlasTin reagent
• Code Information: Models: 290001 999001 with SN''s beginning with 05041164 280000 with S/N''s beginning with 0505354
• Recalling Firm/ Manufacturer: Instrumentation Laboratory Co.; 113 Hartwell Ave; Lexington MA 02421-3125
• For Additional Information Contact: Carol Marble; 781-861-4467
• Manufacturer Reason for Recall: Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
• FDA Determined Cause: Other
• Action: Instrumentation Laboratory issued an 'Urgent Product Notification' on 5/19/2005 to Beckman Coulter, Miami FL (DIstributor) to provide the written notification and advise customers to review PT curves an any patient on anticagulant treatment who reports a low result , and manually view the curve where a PT is flagged. A software upgrade will be availabel in July 2005.
• Quantity in Commerce: 617 units
• Distribution: Nationwide Canada
• 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