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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73129

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

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Event summary

Timeline bucket
January 22, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sekisui Diagnostics P.E.I. 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

Sekure Chemistry Sekisui Diagnostics Acetaminophen L3K Assay, In-vitro Diagnostic Catalog Number: 506-10: R1: 1 x 10ml, R2: 2 x 10ml Catalog Number: 506-30: R1: 3 x 10ml, R2: 6 x 10ml In-Vitro quantitative measurement of Acetaminophen in serum and plasma used m the diagnosis and treatment of acetaminophen overdose toxicity.

Z-1171-2016
Recall number
Z-1171-2016
Initiated
January 22, 2016
Classification
Class II
Status
Terminated
Quantity
14,407 kits.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Crystal formation in the Color Reagent (R2) when left on board automated analyzers causing samples to under recover

Code information

Catalog Number: 506-10 Lot Codes 47677 47694 47649 47650 47662 47663 48253 48385 48386 Catalog Number: 506-30 Lot Codes: 47695 48294

Distribution pattern

Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, IA, ID, IL, MA, , MN, MT and ND., and to the countries of Canada, France and Hong Kong.