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U.S. Department of Health and Human Services

Class 2 Device Recall Radiometer ABL90 FLEX Analyzer

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  Class 2 Device Recall Radiometer ABL90 FLEX Analyzer see related information
Date Initiated by Firm April 14, 2021
Create Date June 15, 2021
Recall Status1 Open3, Classified
Recall Number Z-1856-2021
Recall Event ID 87870
510(K)Number K092686  
Product Classification Electrode, ion specific, potassium - Product Code CEM
Product Radiometer ABL90 FLEX Analyzer with E3800 PC units.

The E3800 CPU is also used as spare part.
Code Information Model Number: ABL90 FLEX (393-090)  Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards
Recalling Firm/
Manufacturer		 Radiometer Medical ApS
Akandevej 21
Bronshoj Denmark
For Additional Information Contact Technical Support, Radiometer America, Inc
800-736-0600 Ext. 1
Manufacturer Reason
for Recall		 Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.
FDA Determined
Cause 2		 Device Design
Action On 04/14/2021, the firm initially sent an "Urgent: Medical Device Recall" Letter via email with a follow-up hardcopy via FedEx 2nd Day to customers inform them the Recalling Firm has become aware of a potential for the analyzers internal clocks may become incorrect. For analyzers which do not have an internal battery installed the incorrect time may be triggered in case power is abruptly removed from the analyzer, by e.g. toggling the power switch on the analyzer itself or at the wall outlet, or a power failure occurs on the mains supply. When the analyzer is switched on again, the analyzers internal clock may behave as in the example below: -The clock starts at 08:00 -The clock runs normally until it reaches 08:59:59 -The clock resets to 08:00 Once the issue has been triggered the clock will continue to run in an infinite loop between 08:00 and 08:59 and the date will remain the same. This means that all patient samples run after the issue has been triggered will have a time stamp suggesting they have been run between 08:00 and 08:59 on the same day. This situation has the following additional consequences: -Scheduled Quality Controls (QC) are not run -Scheduled Calibrations are not run -No notification of scheduled replacements & maintenance activities -No notification of expiration of Sensor Cassette (SC) and Solution Pack (SP) -Analyzer can accept expired consumables -Expired Sample age not error marked -Reference ranges and critical limits flagging based on wrong patient age -Incorrect time stamp on results and messages send to external systems such as AQURE and HIS/LIS. Risks for the Patients-The described error is considered to have a possibility of resulting in immediate as well as long range serious or life-threatening adverse health consequences to the patient. The described error may lead to the analyzers reporting negative as well as positive biases for all parameters outside the analyzer specifications, as Calibrations are not perfor
Quantity in Commerce Total=3,346 analyzers world-wide (only 2 analyzers within the U.S.)
Distribution Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CEM and Original Applicant = RADIOMETER MEDICAL APS
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