FDAFDA · Food and drugs·Recall number 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.
Published July 27, 2016 · Recall initiated: May 17, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CSL Behring GmbH
- Distributor
- Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV
- Lot
- Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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