CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report
pocH-100i; sysmex; Automated Hematology Analyzer recalled
Sysmex America is recalling pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" /; Sysmex, distributed nationwide in the US. The recall was initiated on 15 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0100-2014
- FDA event ID
- 65722
- Recalling firm
- Sysmex America, Lincolnshire, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 May 2013
- FDA classified
- 29 Oct 2013
- Reported
- 6 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 15 May 2013 | Recall initiated by company | |
| 29 Oct 2013 | Classified by FDA | +167 days |
| 6 Nov 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Product as listed by the FDA
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).
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriMontanaNorth Carolina
Questions about this recall
Why was it recalled?
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
Which lots are affected?
Product Code: 023-1861-8; 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, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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