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

Recall Z-0445-2013 — The Is-anti-Sm test kits**Catalog No: 720-240* Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results are reported in ELISA

U.S. FDA — Device Enforcement · United States · 2012-08-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0445-2013
Date of alert: 2012-08-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Diamedix Corporation
Product category: device
Product type: Devices

Reported risk: Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.

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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