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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97863

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

Open FDA event record

Event summary

Timeline bucket
October 21, 2025
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Accriva Diagnostics, 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

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

Z-0500-2026
Recall number
Z-0500-2026
Initiated
October 21, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Accriva Diagnostics, Inc.
Quantity
125 boxes (3,125 tests)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an device without a premarket clearance being incorrectly package and distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an device without a premarket clearance being incorrectly package and distributed.

Code information

Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.