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.
Reported: July 27, 2016 Initiated: May 17, 2016 #Z-2241-2016
Product Description
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.
Reason for Recall
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.
Details
- Recalling Firm
- CSL Behring GmbH
- Units Affected
- 898 units
- Distribution
- 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
- Location
- Marburg, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CSL Behring GmbH. Units affected: 898 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2241-2016.
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