Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81356

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

Open FDA event record

Event summary

Timeline bucket
April 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Helena Laboratories, 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

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

Z-0594-2019
Recall number
Z-0594-2019
Initiated
April 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
Helena Laboratories, Inc.
Quantity
12 Kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

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

Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

Code information

Lot Codes: 1-15-5701 Model/Catalog Number: 5701

Distribution pattern

US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.