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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87621

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

Open FDA event record

Event summary

Timeline bucket
March 19, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Cytocell Ltd.

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

Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481

Z-1493-2021
Recall number
Z-1493-2021
Initiated
March 19, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cytocell Ltd.
Quantity
89 probes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.

Code information

Lot: RD20/253/16, RD21/043/01, RD21/043/02

Distribution pattern

US Nationwide distribution in the states of TX, OH, NY, IL, CT, AL, IA, MO.