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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87047

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

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Event summary

Timeline bucket
December 11, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Qiagen Sciences LLC

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

therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

Z-0937-2021
Recall number
Z-0937-2021
Initiated
December 11, 2020
Classification
Class II
Status
Terminated
Recalling firm
Qiagen Sciences LLC
Quantity
575 kits US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kit may generate false Q546R mutation positive results caused by nonspecific molecular interactions within the Q546R higher than previously observed and described within the Instructions For Use.

Code information

All lots

Distribution pattern

CA, IN, MI, MN, NC, NJ, NM, OH, TX