Siemens Healthcare recalls Dimension Vista CTNI Sample Diluent KD692 (SMN# 10445205) due to potential for incorrect test results from defective vial caps. Affected units have incomplete septums that may cause erroneous elevations in test results when autodiluted.
The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sample is autodiluted onboard the system, due to a reduced volume of diluent being pipetted from the vial.
Siemens Healthcare is recalling Dimension Vista CTNI Sample Diluent KD692 vials because some have a defective cap septum that can cause test results to be too high when used with their system. This could lead to inaccurate medical diagnoses if the diluent is used without proper testing.
The vial cap may have an incomplete slit on the septum, which can cause less diluent to be properly measured when the sample is autodiluted in the system. This leads to higher test results than intended, potentially causing incorrect medical diagnoses.
Healthcare facilities using Siemens Dimension Vista CTNI Sample Diluent KD692 vials with lot # 17171BD are affected. Laboratory staff and medical professionals who handle these vials during testing are most at risk of inaccurate results.
Check for vials labeled 'Dimension Vista CTNI Sample Diluent, KD692' with serial number SMN# 10445205 and lot number 17171BD. The affected vials may have a cap with a defective septum that causes inaccurate test results.
Inspect the vial cap for an incomplete slit on the septum that may cause inaccurate test results.
The diluent may have an incomplete slit on the septum in the cap of the vial, which can cause erroneously elevated test results when autodiluted in the system.
Check the vial cap for an incomplete slit on the septum. If found, stop using it and contact Siemens Healthcare for further instructions.
The recall record does not mention a specific fix or remedy for the defective vials.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2436-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2436-2018 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.
