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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

Compare all device evidence states

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.

Field note

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