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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79872

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

Open FDA event record

Event summary

Timeline bucket
April 04, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
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 Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.

Z-1530-2018
Recall number
Z-1530-2018
Initiated
April 04, 2018
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.

Code information

UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)

Distribution pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy