Z-0161-2027Class II

Iq200 Sprint, Ref: 700-3322,700-3322Rfb, 700-3325, 700-3326, B48997; Iq200 Select, Ref: 700-3340, 700-3345...

Name: Z-0161-2027 Iq200 Sprint, Ref: 700-3322,700-3322Rfb, 700-3325, 700-3326, B48997; Iq200 Select, Ref: 700-3340, 700-3345...
Creator: Beckman Coulter, Inc.
Published: 2026-08-12
License: https://open.fda.gov/license/

Beckman Coulter, Inc. / initiated 2026-08-12 / Open, Classified

FDA source

Recall record

Recall number: Z-0161-2027
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-12
Posted: 2026-10-15
Recalling firm: Beckman Coulter, Inc.
Product: 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
Product code: KQO Automated Urinalysis System
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.
FDA root cause: Component design/selection
Action: On 8/12/2026, recall notices were mailed and emailed to customers asking them to take the following actions: 1) Perform the daily Cleaning Instrument Surfaces maintenance described in Chapter 12, Maintenance Procedure of the DxU 840/850m Instructions for Use (PN# C49320AB), (PN# D38676AA), or iQ200 Instructions for Use (PN# 300-4320CE), (PN# 300-4321EE). During the cleaning, inspect the instrument for signs of lamina leakage, including fluid accumulation on or around the instrument, or evidence of fluid on the laboratory bench or floor. If you determine that there is a leak, discontinue use of the analyzer and clean any spilled fluid in accordance with your laboratory's safety procedure. 2) Contact the firm's Technical Support Organization immediately if evidence of leakage is observed. 3) Continue routine operation, if no leakage is observed, while maintaining increased awareness for the symptoms described in the impact section of this letter. 4) Post this letter on or near affected Analyzers. 5) Share this information with laboratory staff and retain this notification. If you have forwarded any of the affected products to another laboratory, please provide them a copy of this letter. Firm is investigating this issue and will continue to address any reported lamina fluid leakage through its Technical Support Organization until this issue has been fully resolved. If you have any questions regarding this notice, please contact the firm's Customer Support Center: http://www.beckmancoulter.com or 1-800-854-3633 in the United States and Canada.
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.
Product codes and lots: Product/UDI-DI: IQ200 SPRINT/10837461001256, IQ200 SELECT/10837461001300, IQ200 ELITE/10837461001355. All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0161-2027
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0160-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15
Z-0161-2027	Class II	Ongoing	Voluntary: Firm initiated	2026-10-21	2026-10-15

Product code KQO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-10-21. View this recall on fda.gov (opens on fda.gov)