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U.S. Department of Health and Human Services

Class 2 Device Recall ABL8O FLEX

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  Class 2 Device Recall ABL8O FLEX see related information
Date Initiated by Firm June 04, 2007
Date Posted August 29, 2007
Recall Status1 Terminated 3 on February 29, 2012
Recall Number Z-1201-2007
Recall Event ID 38350
510(K)Number K051804  
Product Classification in vitro diagnostic analyzer software - Product Code CHL
Product ABL8O FLEX Software Version 1.10 included in the ABL8O Flex Analyzer, Model Number 914863
Code Information Software Version 1.10 Lot numbers: 17293, 17384, 17440, 17515, 17572 and 17663.
Recalling Firm/
Manufacturer		 Sendx Medical Inc
1945 Palomar Oaks Way
Carlsbad CA 92009-1307
For Additional Information Contact Doreen E. Milford
760-603-3401
Manufacturer Reason
for Recall		 The ABL8O FLEX software version 1.10 contains errors in the derived parameter calculation for cBase(B,ox) and cBase(Ecf,ox). These incorrect calculations result in a mild to moderate lowering of the base excess value, the severity depending on the concentration of hemoglobin and the oxygen saturation in the sample. Elevated hemoglobin concentrations have the greatest impact on this calculation err
FDA Determined
Cause 2		 Other
Action A total of eight (8) distributors and the Radiometer main office in Denmark were sent the recall package (Field Action Notice) by email on 6-6-07. The distributors were provided background information and specific instruction on the steps to perform to correct the problem. The Recall package included a Management Cover for Field Action Notes and the Field Action Notice. Radiometer has released a subsequent software upgrade (v.1.11) to correct the two problems noted in the Recall Notice.
Quantity in Commerce 165 software upgrade CDs
Distribution In US to Cleveland, OH and Worldwide to Belgium, Denmark, France, Germany, The Netherlands, Sweden & United Kingdom
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 = SENDX MEDICAL, INC.
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