Recall Z-0160-2027 ยท KQO Automated Urinalysis System
Beckman Coulter, Inc.
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513
| Date | Oct 15, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| Reason | 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 result |
| 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 |
| Quantity | 2,088 |
| 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 c |
| FDA record | Open on fda.gov |