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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72311

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

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Event summary

Timeline bucket
September 22, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sentinel CH SpA

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

Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

Z-0164-2016
Recall number
Z-0164-2016
Initiated
September 22, 2015
Classification
Class II
Status
Terminated
Recalling firm
Sentinel CH SpA
Quantity
765 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

Code information

Lot 50083Y600, expiration date 31 Jul 2016.

Distribution pattern

Nationwide Distribution.