FDA recall, , Moderate risk
Beckman Coulter DxU 840m Iris, DxU 850m Iris, IQ200 Sprint Analyzers
The DxU 840m Iris, DxU 850m Iris, IQ200 Sprint, IQ200 Select, and IQ200 Elite may leak lamina fluid, posing slip, chemical.
Summary by Recall Canary from the FDA notice
What happened
Beckman Coulter, Inc. is recalling the DxU 840m Iris, DxU 850m Iris, IQ200 Sprint, IQ200 Select, and IQ200 Elite because the rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage. The check valve replacement was excluded from the annual preventive maintenance requirements without adequate reliability evaluation, which may lead to lamina fluid leakage.
The recall began on August 12, 2026, and was added to the FDA's Enforcement Report on October 15, 2026. The products were distributed nationwide in the United States and worldwide, including in states and territories such as CA, NE, FL, and NY, and countries including Canada, Mexico, Switzerland, and Japan. The agency stated that when the check valve is not replaced annually, the leakage can occur.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI, model number and reference number are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
DxU 840m Iris
- UDI-DI
- 15099590748654
- 15099590748647
- Model number
- 840m
- 850m
- Reference number
- C76947
- Lot code
- All Serial Numbers
DxU 850m Iris
- UDI-DI
- 15099590748654
- 15099590748647
- Model number
- 840m
- 850m
- Reference number
- C49513
- Lot code
- All Serial Numbers
IQ200 Sprint, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 Select, REF: 700-3340, 700-3345, 700-3347, B48998, C10684; IQ200 Elite, REF: 700-3370, 700-3375, 700-3375RFB, 700-3376, B48999, C10683
- UDI-DI
- 10837461001256
- 10837461001300
- 10837461001355
- Model number
- IQ200
- Lot code
- All Serial Numbers
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states and territory of CA, NE, FL, NY, MA, MD, SC, WI, TX, OH, VA, PA, IL, NH, KS, GA, NC, IA, PR, TN, OR, UT, NJ, MI, CO, NM, MS, LA, RI, OK, WA, MO, ME, IN, CT, AZ, AR, MT, MN, ID, DE, AL, WV, DC, KY, NV, WY, ND, HI, AK, SD, VT, GU and the countries of Canada, Mexico, Switzerland, Panama, Ecuador, Japan, Hungary, Italy, Belgium, China, Germany, France, United Kingdom of Great Britain and Northern Ireland, Russian Federation, Singapore, Romania, Argentina, Israel, Spain, Belarus, Guatemala, Colombia, Qatar, Czechia, Reunion, Australia, United Arab Emirates, Poland, Croatia, Brazil, Slovakia, New Zealand, Saudi Arabia, Thailand, Republic of Korea, Serbia, Austria, Macao, Ukraine, India, Netherlands, Taiwan, South Africa, Sint Maarten, Bangladesh, Hong Kong, Viet Nam, Bahrain, Uganda, Lebanon, Morocco, Guadeloupe, Greece, Curacao, Republic of Moldova, Malaysia, Ghana, Indonesia, Lithuania, Portugal, Kazakhstan, Georgia, Philippines, Bosnia and Herzegovina, Libya, Kuwait, Oman, Jordan, Uzbekistan.
- Company
- Beckman Coulter, Inc.
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99832
- Recall numbers
- Z-0160-2027 to Z-0161-2027
All recalls from Beckman Coulter, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
