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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65770

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

Open FDA event record

Event summary

Timeline bucket
May 13, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Life Technologies Corporation

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

HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.

Z-2085-2013
Recall number
Z-2085-2013
Initiated
May 13, 2013
Classification
Class II
Status
Terminated
Quantity
15 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA.

Code information

Catalog #18081020, Lot #1368760 & Lot #1312093

Distribution pattern

USA Nationwide Distribution in the states of DE, IA, MN, and NC.