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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84759

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

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Event summary

Timeline bucket
January 21, 2020
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

Sysmex CV-11 Sample Unit, an integrated modular sampler that conveys specimens to either the UF-5000 or UD-10 analyzers.

Z-1717-2020
Recall number
Z-1717-2020
Initiated
January 21, 2020
Classification
Class II
Status
Terminated
Recalling firm
Sysmex America, Inc.
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.

Code information

Serial Numbers: 11201, 11202, 12310, 12311, 12312, 12313, 12941, 12942, 12997, 13875, 14170, 14171, 14172, 14173, 14174, 14175, 14278, 14279, 14280, 14962, 14963, 14964, 14965, 14966, 14967, 14968, 14969, 14970, 14972, 14973, 14974, 14975, 14976, 14977, 14978, 14979, 15017, 15018, 15619, 15620

Distribution pattern

USA: FL, VT, IL.