Beckman Coulter, Inc. 2023-05-24 Health serious FDA
Health · FDA · Recall #FDA-Z-1598-2023
DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic… Recall
Issued May 24, 2023 · Beckman Coulter, Inc.
In May 2023, Beckman Coulter, Inc. recalled the DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
What you should do
- 1 Stop using DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter, Inc. 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
- Beckman Coulter, Inc.
- Category
- Health
- Recall date
- May 24, 2023
- Units affected
- Not reported
- Sold at
- Worldwide Distribution
- Recall number
- FDA-Z-1598-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Beckman Coulter, Inc. has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.