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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89914

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 25, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

2 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 2

therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

Z-0951-2022
Recall number
Z-0951-2022
Initiated
February 25, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Qiagen Sciences LLC
Quantity
435 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

Code information

All lot numbers. GTIN number: 04053228002048

Distribution pattern

AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV

device · product 2 of 2

therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

Z-0952-2022
Recall number
Z-0952-2022
Initiated
February 25, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Qiagen Sciences LLC
Quantity
8 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

False positive or false negative G12C (12CYS) mutation result for the KRAS Mutation Status resulting from Flags/Warnings may invalidate the result for one or more individual mutation target of the kit.

Code information

All lot numbers

Distribution pattern

AZ CA CT FL GA IL IN MA MN NC NY OK OR PA TN TX WV