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
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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 |
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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
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