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

Recall Z-2241-2016 — Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

U.S. FDA — Device Enforcement · Germany · 2016-05-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2241-2016
Date of alert: 2016-05-17
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: CSL Behring GmbH
Product category: device
Product type: Devices

Reported risk: Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.

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

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Recall Z-2241-2016 — Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.

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