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U.S. Department of Health and Human Services

Class 2 Device Recall Instrumentation Laboratory (IL)

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  Class 2 Device Recall Instrumentation Laboratory (IL) see related information
Date Initiated by Firm March 07, 2003
Date Posted May 20, 2003
Recall Status1 Terminated 3 on May 23, 2012
Recall Number Z-0845-03
Recall Event ID 25810
510(K)Number K992834  
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
Product GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge.
Part No. 24330004 (300 Sample Size)
For In-Vitro Diagnostic Use
Code Information Lot Number: 306355 Expires: 8/31/2003
Recalling Firm/
Instrumentation Laboratory Co.
113 Hartwell Avenue
Lexington MA 02173
For Additional Information Contact Carol Marble
Manufacturer Reason
for Recall
Incorrect bar code applied to cartridges could result in inaccurate pO2 value
FDA Determined
Cause 2
Action IL notifed customers by telephone on 3/7/03, requesting the return or discard of the cartridges.
Quantity in Commerce 16
Distribution CA, FL, NY, PA, TN,
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 = CHL and Original Applicant = INSTRUMENTATION LABORATORY CO.