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.
FDA Recall Z-2241-2016 · Posted None
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Recalling FirmCSL Behring GmbH
Recall StatusTerminated
Product CodeLPS
Date Initiated2016-05-17
Date Terminated2018-02-07
Product Quantity898 units
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.
Firm Action
Siemens mailed an Urgent Medical Device Recall to all customers who received the affected lots notifying them of the following: 1) Discontinue use and discard any remaining inventory of the affected lots, and 2) Indicate their replacement product needs within 30 days.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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