Summary
The FDA issued a Class II for DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 by Beckman Coulter, Inc.. Reason: The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; h.
Details
Source
Device Recall
External ID
Z-0160-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
Lot/Code Info: Product/UDI-DI: DxU 840m/15099590748654, DxU 850m/15099590748647. All Serial Numbers
Quantity Affected: 2,088
Reason for Recall
The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-12
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Beckman Coulter, Inc. has 156 FDA actions in our database, including 109 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 156 FDA actions in our database, including 109 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0160-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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