Dimension Vista Gentamicin Flex reagent cartridge — Class II medical device recall Z-2182-2018
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2018-06-20, distributed nationwide. The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analyti
| Recall number | Z-2182-2018 |
|---|---|
| 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 | 2018-04-19 |
| Classified | 2018-06-13 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BR, BS, CA, DE, IN, JP, NZ, SA, TW, ZA |
| Quantity | 20,373 |
| Lot numbers | 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, 17312BB |
Product
Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
Reason for recall
The affected lots may exhibit inaccuracy for Quality Control and patient samples at the low end of the Analytical Measurement Range. The bias is due to the calibration curve not showing separation between the Level 1 and Level 2 calibrators. The negative bias observed for patient, QC, and calibrator samples, when using any of the listed lots, has the potential to impact the interpretation of gentamicin results during therapeutic monitoring at concentrations up to approximately 2.5 ¿g/mL [5.4 ¿mol/L].
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-2182-2018. 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.