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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70054

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

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Event summary

Timeline bucket
December 18, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sysmex Corporation

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

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.

Z-1945-2016
Recall number
Z-1945-2016
Initiated
December 18, 2014
Classification
Class II
Status
Terminated
Recalling firm
Sysmex Corporation
Quantity
1,137 units (US) 54 units (Canada) 9 inventory

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.

Code information

1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484; 2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.

Distribution pattern

Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam. THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.