The XN-Series modules — Class II medical device recall Z-1945-2016
Terminated recall by Sysmex Corporation, reported 2016-06-22, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
| Recall number | Z-1945-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sysmex Corporation, Kobe-shi, Japan |
| Recall initiated | 2014-12-18 |
| Classified | 2016-06-10 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-07-25 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY |
| Countries outside the US | AU, BD, BH, CA, CN, DE, HK, ID, IN, KR, LK, MY, NP, NZ, PH, PK, SG, TH, TW, VN |
| Serial numbers | 11001-12118, 111001-15483 |
| Model numbers | AE797961, AP795756, XN-10, XN-20 |
Product
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Reason for recall
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
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-1945-2016. 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.