Exact FDA event identifier

Event 62017

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

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Event summary

Timeline bucket: May 29, 2012
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sekisui Diagnostics Llc

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

MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.

Z-1902-2012

Recall number: Z-1902-2012
Initiated: May 29, 2012
Classification: Class II
Status: Terminated
Recalling firm: Sekisui Diagnostics Llc
Quantity: 1600 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

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Inspect official wording and provenance

Reason for recall

Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.

Code information

Lot 41928UQ11 {exp 2013-01 -31 )

Distribution pattern

Illinois