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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65722

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 15, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sysmex America Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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).

Z-0100-2014
Recall number
Z-0100-2014
Initiated
May 15, 2013
Classification
Class II
Status
Terminated
Recalling firm
Sysmex America Inc
Quantity
193 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.

Code information

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

Distribution pattern

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.