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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66310

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

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Event summary

Timeline bucket
September 05, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Perkin Elmer 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

Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

Z-0030-2014
Recall number
Z-0030-2014
Initiated
September 05, 2013
Classification
Class II
Status
Terminated
Quantity
65,984 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some devices may be contaminated on the back side of the device with glue in the blood application area.

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

Some devices may be contaminated on the back side of the device with glue in the blood application area.

Code information

Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.

Distribution pattern

US distribution in OH