# Class II recall Z-0161-2027: Beckman Coulter, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0161-2027 |
| Recalling firm | Beckman Coulter, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 |
| 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 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 c |
| Recall initiated | 2026-08-12 |
| Reported | 2026-10-21 |
| Firm location | Miami, FL, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 14 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0161-2027%22). Last refreshed: 2026-11-03T18:05:14.713Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.