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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87151

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

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Event summary

Timeline bucket
January 05, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Helena Laboratories, Corp.

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 aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

Z-1108-2021
Recall number
Z-1108-2021
Initiated
January 05, 2021
Classification
Class II
Status
Terminated
Quantity
205 total kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Intermittent potential for shorter than expected clot times.

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

Intermittent potential for shorter than expected clot times.

Code information

Model Number: 5722 Lot Numbers: 1-20-5722 expiration date 90/30/2021; 3-20-5722 expiration date 11/30/2021; 4-20-5722 expiration date 12/31/2021

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.