Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The… — Class II medical device recall Z-1141-2017
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2017-02-15, distributed nationwide. Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lot
| Recall number | Z-1141-2017 |
|---|---|
| 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 | 2016-12-16 |
| Classified | 2017-02-06 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2018-01-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, DE, DK, EC, EG, ES, FR, GB, HK, HR, HU, ID, IL, IN, IT, JP, KR, LB, LK, MX, MY, NI, NZ, PH, PL, PT, RS, SA, SI, SK, TR, TW, UY, VE, ZA |
| Quantity | 8,032 units |
| Reason classes | potency |
| Lot numbers | 16187BE, 16225BB, 16265AB |
Product
Dimension Vista¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic test for the quantitative measurement of ammonia in human plasma on the Dimension clinical chemistry system. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders such as cirrhosis, hepatitis and Reye s syndrome
Reason for recall
Siemens Healthcare Diagnostics has determined that Dimension Vista AMM (K3119) Flex reagent cartridge flex lots 16187BE, 16225BB, 16265AB do not meet the 60-day calibration interval claim due to reagent instability and results may show an Abnormal Assay.
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-1141-2017. 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.