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
Recalling firm: Thermo Fisher Scientific (Monterrey)
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