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

Recall Z-2922-2018 — is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent assay (ELISA) for the detection, in human serum or plasma, of antibodies specific for the Scl-70 antigen. The test is intended to as an aid to the diagnosis of scleroderma and is not definitive in isolation. Autoantibody levels

U.S. FDA — Device Enforcement · Sweden · 2016-10-21 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2922-2018
Date of alert: 2016-10-21
Country / jurisdiction: Sweden
Risk level: Class III
Risk type: recall
Brand: Euro Diagnostica AB
Product category: device
Product type: Devices

Reported risk: Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin.

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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