Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge — Class II medical device recall Z-2450-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-09-02, distributed nationwide. customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using F
| Recall number | Z-2450-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-07-23 |
| Classified | 2015-08-21 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,655 units |
| Reason classes | potency |
| Lot numbers | 15037MA, 15175MA, 15204MA, 15246MA, 15267MA |
| Expiration dates | 2015-11-17, 2016-07-14, 2017-01-13, 2017-02-26 |
Product
Dimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B¿2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B¿2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Reason for recall
customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC various lots. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.
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-2450-2015. 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.