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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66331

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

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Event summary

Timeline bucket
September 04, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SEPPIM SAS

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

Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

Z-0178-2014
Recall number
Z-0178-2014
Initiated
September 04, 2013
Classification
Class II
Status
Terminated
Recalling firm
SEPPIM SAS
Quantity
47 kits in US and 48 kits in Sweden

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.

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

Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum.

Code information

Lot numbers distributed in the US: Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014. Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408

Distribution pattern

Worldwide Distribution - US including the states of KY and UT and the country of Sweden.