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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83622

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

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Event summary

Timeline bucket
July 21, 2017
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

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Z-0045-2020
Recall number
Z-0045-2020
Initiated
July 21, 2017
Classification
Class II
Status
Terminated
Quantity
24 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The plates do not have wells punched for the controls in the patient 1 area.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The plates do not have wells punched for the controls in the patient 1 area.

Code information

Lot 35-17-552583, exp. date 4/30/2018

Distribution pattern

Distribution was made to IN, KY, MA, OH, OR, TN, and TX. There was government distribution. Foreign distribution was made to Chile.