Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75862

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

Open FDA event record

Event summary

Timeline bucket
December 05, 2016
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
PerkinElmer Health Sciences, Inc.

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

EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U

Z-0897-2017
Recall number
Z-0897-2017
Initiated
December 05, 2016
Classification
Class III
Status
Terminated
Quantity
73 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unique Device Identifier (UDI) is missing from outer kit box label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unique Device Identifier (UDI) is missing from outer kit box label.

Code information

Lot Number: 1065060401

Distribution pattern

MA, AK