Dimension Vista¿ Homocysteine Flex Reagent Cartridge — Class II medical device recall Z-2241-2016
Terminated recall by CSL Behring GmbH, reported 2016-07-27, distributed in AL, AR, CA, CO, CT, DC, DE, FL…. Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions F
| Recall number | Z-2241-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CSL Behring GmbH, Marburg, N/A, Germany |
| Recall initiated | 2016-05-17 |
| Classified | 2016-07-19 |
| Reported by FDA | 2016-07-27 |
| Terminated | 2018-02-07 |
| Distributed | 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 |
| Quantity | 898 units |
| Reason classes | specification failure |
| Lot numbers | 15243MA, 15243MB |
| Expiration dates | 2016-05-31 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2241-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.