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U.S. Department of Health and Human Services

Class 2 Device Recall The ABL90 FLEX Analyzer

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  Class 2 Device Recall The ABL90 FLEX Analyzer see related information
Date Initiated by Firm May 25, 2018
Create Date October 01, 2018
Recall Status1 Terminated 3 on November 06, 2020
Recall Number Z-0010-2019
Recall Event ID 80718
510(K)Number K120197  
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Product ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

It is intended for use in a laboratory environment, near patient or point-of-care setting.
Code Information ABL90 FLEX analyzers with software versions 3.3MR1 or below.
Recalling Firm/
Manufacturer		 Radiometer America Inc
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 The ABL90 FLEX can aspirate Cal 2 solution instead of rinse solution, when the following take place: ¿ The analyzer is in ready mode ¿ Operator lifts the inlet and then closes it again, thereby initiating a rinse ¿ Immediately after lifts the inlet and quickly closes it again
FDA Determined
Cause 2		 Device Design
Action The firm, Radiometer America, Inc., notified customers via letter dated 05/25/2015. The letter provided the following: Reason for recall, Affect product description and codes, Risk for the patient, What customers must do, Countermeasure provided by Radiometer, contact information and Response Form. The customers were instructed to do the following: 1. Inform users of the ABL90 FLEX analyzer that the inlet is not to be repeatedly lifted and closed. If this does happen, the easiest way to reset the analyzer flow selector manually is to re-install the solution pack. Follow the procedure described in the IFU for installation of a solution pack. You may re-use the same solution pack. 2. We recommend that you review previous results, where cNa+ and cCl- results are off from the expected results with the values found in table 1. 3. Complete the recall response fax form (last page of this customer advisory letter) and submit to your Radiometer representative via Fax to:714 582 0806. If you have any questions, please contact your Radiometer representative or Quality Assurance/ Regulatory Affairs Manager at 1-800-736-0600 opt.4.
Quantity in Commerce 12,102
Distribution US Distribution and Internationally to 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 = JJE and Original Applicant = RADIOMETER MEDICAL APS
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