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

Recall Z-0594-2019 — Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effe

U.S. FDA — Device Enforcement · United States · 2016-04-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0594-2019
Date of alert: 2016-04-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Helena Laboratories, Inc.
Product category: device
Product type: Devices

Reported risk: Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

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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