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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80404

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

Open FDA event record

Event summary

Timeline bucket
May 18, 2018
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Qiagen 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

AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.

Z-2577-2018
Recall number
Z-2577-2018
Initiated
May 18, 2018
Classification
Class I
Status
Terminated
Recalling firm
Qiagen Sciences, Inc.
Quantity
1620 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for control line not appearing on the test strip

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

Potential for control line not appearing on the test strip

Code information

1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020

Distribution pattern

Worldwide - US Nationwide distribution an in the country of , Canada