Siemens Healthcare recalls Dimension Vista Gentamicin Flex reagent cartridges (lots 17135BC, 17150BF, etc.) due to potential inaccuracy in gentamicin testing at low concentrations, which could lead to incorrect dosing decisions.
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].
Siemens Healthcare is recalling Dimension Vista Gentamicin Flex reagent cartridges because some lots may give inaccurate gentamicin test results at low concentrations. This could lead to incorrect dosing decisions for patients receiving gentamicin antibiotics.
The affected lots may produce inaccurate results for patient samples and quality control tests at low gentamicin concentrations. This happens because the calibration curve does not properly separate Level 1 and Level 2 calibrators, causing a negative bias in measurements. The inaccuracy could lead to incorrect dosing decisions for patients.
Healthcare facilities using Siemens Dimension Vista Gentamicin Flex reagent cartridges for gentamicin testing are affected. Patients receiving gentamicin antibiotics through this testing system may be at risk of incorrect dosing.
Check the lot number on the cartridge label. Affected lots include 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB. These were sold in specific timeframes but the exact dates are not stated in the recall.
Look for the lot number on the cartridge label to determine if it is affected (17135BC, 17150BF, 17159BD, 17178AC, 17269BD, or 17312BB).
The affected lots may exhibit inaccuracy for quality control and patient samples at low gentamicin concentrations, causing a negative bias in measurements that could lead to incorrect dosing decisions.
Affected lots are 17135BC, 17150BF, 17159BD, 17178AC, 17269BD, and 17312BB.
Inaccurate results could lead to incorrect dosing decisions for patients receiving gentamicin antibiotics, potentially affecting treatment effectiveness or safety.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2182-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2182-2018 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
