Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0178-2014 — 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 diagno

U.S. FDA — Device Enforcement · France · 2013-09-04 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0178-2014
Date of alert: 2013-09-04
Country / jurisdiction: France
Risk level: Class II
Risk type: recall
Brand: SEPPIM SAS
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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