Siemens Dimension Vista Akaline Phosphatase — Class II medical device recall Z-0134-2021
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2020-10-28, distributed nationwide. Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference ob
| Recall number | Z-0134-2021 |
|---|---|
| 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 | 2020-08-25 |
| Classified | 2020-10-20 |
| Reported by FDA | 2020-10-28 |
| Terminated | 2023-05-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BS, CA, CH, CZ, DE, DK, ES, FR, IT, JP, KR, NL, NO, NZ, PT, SI, SK |
| Model numbers | 10642444, K2115 |
| Expiration dates | 2020-09-03, 2020-10-08, 2020-11-25 |
Product
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma Catalog Number: K2115, SMN# 10642444
Reason for recall
Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
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-0134-2021. 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.