pocH-100i — Class II medical device recall Z-0100-2014
Terminated recall by Sysmex America Inc, reported 2013-11-06, distributed nationwide. The data printed on the thermal printer may omit a digit or decimal point in the results or sample identificat
| Recall number | Z-0100-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex America Inc, Lincolnshire, IL, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2016-08-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 193 units |
| Serial numbers | B1677, B1826, F1827, F2161, F2178, F2198, F2216, F2396, F2411, F2452, F2464, F2472, F2495, F2523, F2533, F2550, F2560, F2592, F2601, F2614, F2635, F2640, F2648, F2662, F2679 and 16 more |
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 %/#, MIXED %/# (EO, BSO, MONO).
Reason for recall
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
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-0100-2014. 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.