Siemens Healthcare recalls Dimension Gentamicin Flex reagent cartridges with specific lot numbers due to potential inaccuracy in patient samples and quality control tests at low measurement levels.
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.
Siemens Healthcare is recalling Dimension Gentamicin Flex reagent cartridges with lot numbers EB8115, BB8159, and FB8275. These cartridges may give inaccurate results for patient samples and quality control tests at low levels of gentamicin, which could affect medical testing.
The affected cartridges may not properly separate calibration levels, causing inaccurate measurements at low concentrations of gentamicin. This could lead to incorrect test results for patient samples and quality control checks.
Healthcare facilities using Siemens Dimension Gentamicin Flex reagent cartridges with the affected lot numbers are likely affected. Patients receiving tests using these cartridges could be at risk of inaccurate results.
Check the lot number on the cartridge, which should be one of EB8115, BB8159, or FB8275. The product is a Dimension Gentamicin Flex reagent cartridge for gentamicin enzyme immunoassay testing.
Identify the lot number on the cartridge, which should be EB8115, BB8159, or FB8275.
The affected lot numbers are EB8115, BB8159, and FB8275.
The affected lots may exhibit inaccuracy for patient samples and quality control tests at low levels of gentamicin due to calibration issues.
Check the lot number on the cartridge. If it matches EB8115, BB8159, or FB8275, contact Siemens Healthcare for further instructions.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2181-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2181-2018 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
