Radiometer Medical ApS 2024-07-31 Health serious FDA
Health · FDA · Recall #FDA-Z-2426-2024
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended… Recall
Issued July 31, 2024 · Radiometer Medical ApS
In July 2024, Radiometer Medical ApS recalled the ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
What you should do
- 1 Stop using ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Radiometer Medical ApS to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Radiometer Medical ApS
- Category
- Health
- Recall date
- July 31, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD,
- Recall number
- FDA-Z-2426-2024
- Made in
- Denmark
- Issuing agency
- FDA
In context
- Radiometer Medical ApS has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.