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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 December 16, 2005
Date Posted January 11, 2006
Recall Status1 Terminated 3 on May 21, 2007
Recall Number Z-0378-06
Recall Event ID 34249
510(K)Number K052121  
Product Classification Glucose Oxidase, Glucose - Product Code CGA
Product GEM PREMIER 3000
Code Information Serial numbers starting with 18412
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 error may report higher results for glucose and lactate
FDA Determined
Cause 2
Other
Action Instrumentation Laboratory notified customers by letter dated December 2005 on 12/16/2005. Customers were notifed if the error message occurs the lab should diable the glucose and lactate channels or remove cartridge. A software upgrade will be released in early 2006.
Quantity in Commerce 2021 units
Distribution Nationwide Foreign: 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 = CGA and Original Applicant = INSTRUMENTATION LABORATORY CO.
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