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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63866

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

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Event summary

Timeline bucket
October 10, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alfa Wassermann, 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

Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.

Z-0743-2013
Recall number
Z-0743-2013
Initiated
October 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
Alfa Wassermann, Inc.
Quantity
4,104 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

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

Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.

Code information

Lot Number 155599

Distribution pattern

Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands