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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81378

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

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Event summary

Timeline bucket
February 24, 2017
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

Z-0561-2019
Recall number
Z-0561-2019
Initiated
February 24, 2017
Classification
Class II
Status
Terminated
Recalling firm
Helena Laboratories, Inc.
Quantity
27 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to some cards in this lot reported to have experienced variations in results, (verified by 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 reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

Code information

Lot Codes: 1-16-5701 Model/Catalog Number: 5701

Distribution pattern

US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England