Beckman Coulter Power Express Sample Processing System AU5800XL… — Class II medical device recall Z-1741-2020
Terminated recall by Beckman Coulter Inc., reported 2020-04-29, distributed in AL, CA, CO, DE, FL, GA, IL, IN…. Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm
| Recall number | Z-1741-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2019-05-17 |
| Classified | 2020-04-17 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2022-03-11 |
| Distributed | AL, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, MI, NC, ND, NJ, NY, OH, OR, PA, SD, TN, TX, WA |
| Countries outside the US | AE, AR, AU, CA, CN, CZ, DE, EG, ES, FR, GB, IN, IT, KR, KW, MY, SA, SE, SG, TR, TW, VN |
| Quantity | 291 units |
| Reason classes | software |
| Serial numbers | PW201607008, PW211409001, PW211409002, PW211501001, PW211501002, PW211501003, PW211501004, PW211501005, PW211501006, PW211501007, PW211501008, PW211501010, PW211501011, PW211501012, PW211501013, PW211505001, PW211506001, PW211506002, PW211506003, PW211506004, PW211506005, PW211506006, PW211506007, PW211507001, PW211507002 and 266 more |
| Model numbers | B36351, B36352 |
Product
Beckman Coulter Power Express Sample Processing System AU5800XL connection unit, catalog #B36351; and Power Express Dynamic Inlet, catalog B36352.
Reason for recall
Potential exposure to biohazard. Software design problem causes excess speed and vibrations in the unload arm movement which causes caused sample splashing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1741-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.