Class II — CSL Behring GmbH
| Recalling firm | CSL Behring LLC |
|---|---|
| Registered facility | CSL Behring LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | 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. |
| Quantity | 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 |
| Initiated | 2016-05-17 |
| Classified | 2016-07-19 |
| Terminated | 2018-02-07 |
| Recall number | Z-2241-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CSL Behring GmbH (Z-2241-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74468/
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