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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85561

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

Open FDA event record

Event summary

Timeline bucket
April 29, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Thermo Fisher Scientific (Monterrey)

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

Samco Bio-Tite Sterile Specimen Container, 120mL/53mm, Bio-Tite Blue Cap Catalog Number: 07 0006 The specimen containers are used for temporary collection, transfer, and/or storage of body fluids and solid specimen samples for the purpose of laboratory testing.

Z-2126-2020
Recall number
Z-2126-2020
Initiated
April 29, 2020
Classification
Class II
Status
Terminated
Quantity
78,600 each (786 cartons, 100 devices/carton)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was not irradiated; therefore, they are not sterile and do not meet product specification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was not irradiated; therefore, they are not sterile and do not meet product specification.

Code information

Lot# 1270428, Exp Date: 19 Nov 2021 UDI: (01) 3 7503025 06016 4

Distribution pattern

US Distribution to states of: IL, KY , TX