Calcium Arsenazo — Class II medical device recall Z-0178-2014

Terminated recall by SEPPIM SAS, reported 2013-11-13, distributed in KY, UT. Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high re

Recall number	`Z-0178-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	SEPPIM SAS, SEES, N/A, France
Recall initiated	2013-09-04
Classified	2013-11-07
Reported by FDA	2013-11-13
Terminated	2013-12-12
Distributed	KY, UT
Countries outside the US	SE
Lot numbers	`11-2614`, `12-1002`, `12-2220`
Expiration dates	`2013-07`, `2014-03`, `2014-08`

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0178-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.