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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79421

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

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Event summary

Timeline bucket
November 17, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PerkinElmer Life and Analytical Sciences, Wallac, OY

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

Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.

Z-1541-2018
Recall number
Z-1541-2018
Initiated
November 17, 2017
Classification
Class II
Status
Terminated
Quantity
8

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.

Code information

All software versions from 1.0 to 1.8 (current software version)

Distribution pattern

Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.