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U.S. Department of Health and Human Services

Class 2 Device Recall Instumentation Laboratory

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  Class 2 Device Recall Instumentation Laboratory see related information
Date Initiated by Firm May 19, 2005
Date Posted June 21, 2005
Recall Status1 Terminated 3 on December 06, 2006
Recall Number Z-0915-05
Recall Event ID 32155
510(K)Number K951891  K002400  K033414  
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/
Instrumentation Laboratory Co.
113 Hartwell Ave
Lexington MA 02421-3125
For Additional Information Contact Carol Marble
Manufacturer Reason
for Recall
Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy
FDA Determined
Cause 2
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 and Original Applicant = INSTRUMENTATION LABORATORY CO.