Class II — Sysmex America Inc
| Recalling firm | SYSMEX CORPORATION |
|---|---|
| Registered facility | View this company's 14 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. |
| Product | pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/… |
| Quantity | 193 units |
| Distribution | Worldwide distribution: US (Nationwide) including Puerto Rico and states of: AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and country of Canada. |
| Initiated | 2013-05-15 |
| Classified | 2013-10-29 |
| Terminated | 2016-08-15 |
| Recall number | Z-0100-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sysmex America Inc (Z-0100-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65722/
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