Radiometer Medical ApS Akandevej 21 Bronshoj Denmark ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Brand
Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
Lot Codes / Batch Numbers
Serial Numbers: 902-754R2692N002 and 902-754R2692N001
Products Sold
Serial Numbers: 902-754R2692N002 and 902-754R2692N001
Radiometer Medical ApS Akandevej 21 Bronshoj Denmark is recalling ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 due to Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
Recommended Action
Per FDA guidance
On 3/5/2020 a "Urgent: Medical device Recall" letter was hand delivered to effective consignees. In addition to providing information on the recall products, the customer notification as consignees to take the following actions: Solution provided by Radiometer: 1. Your Radiometer representative will exchange the power supply of your ABL800 analyzer at the earliest convenience. Your Actions: 1. Cease using the affected ABL800 analyzer and put it on quarantine. 2. Shut down the affected ABL800 analyzer and disconnect the power cord. 3. Complete the Recall Response Form (last page of this letter) and submit to your Radiometer representative 4. If you have any questions, please contact us at 1-800-736-0600 option 1, Monday Friday 9am EST to 7pm EST.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN
Page updated: Jan 10, 2026