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

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 — recall Z-0561-2019

U.S. FDA — Device Enforcement · United States · 2017-02-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0561-2019
Date of alert
2017-02-24
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 reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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