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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90417

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

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Event summary

Timeline bucket
May 20, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Menarini Silicon Biosystems

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

CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001

Z-1345-2022
Recall number
Z-1345-2022
Initiated
May 20, 2022
Classification
Class II
Status
Ongoing
Quantity
484 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

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

High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

Code information

UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022

Distribution pattern

CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,