Radiometer Medical ApS: Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Recall number

Z-1856-2021

Recalling firm

Radiometer Medical ApS

Product

Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Status

Open, Classified

Initiated

2021-04-14

Posted

not on file

Terminated

not on file

Reason

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Root cause

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

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.

Lot, serial or model codes

Model Number: ABL90 FLEX (393-090)  Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards

510(k) numbers

["K092686"]

PMA numbers

not on file

Product code

CEM

Firm FEI

3002807968

Firm city

Bronshoj

Firm state

not on file

Firm country

Denmark

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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