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U.S. Department of Health and Human Services

Class 2 Device Recall Instrumentation Laboratory

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  Class 2 Device Recall Instrumentation Laboratory see related information
Date Initiated by Firm March 04, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on January 28, 2016
Recall Number Z-0736-04
Recall Event ID 28485
510(K)Number K951891  
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Product ACL Futura Instrument Analyzer
Code Information Software prior to Version V3.5
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		 Software may cause instrument to omit step causing reagent carrover which may effect patient test result
FDA Determined
Cause 2		 Other
Action Instrumentation Laboratory (IL) notified the Distributor Beckman Coulter, FL by letter on 3/9/04. Beckman will notify customers of the mandatory software upgrade by letter dated 3/4/04 with instructions for the software installation.
Quantity in Commerce 1450 units
Distribution Florida 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.
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