Becton Dickinson recalls BD Veritor System Reader (Catalog 256055) due to potential false test results causing misdiagnosis. Affected units have specific serial numbers listed.
Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment
Becton Dickinson is recalling its BD Veritor System Reader to prevent false test results that could lead to misdiagnosis and inappropriate treatment. This affects specific units with listed serial numbers.
The device's background calibration can produce false positive or false negative results. This may lead to incorrect diagnoses and inappropriate medical treatments if the test results are not accurate.
Healthcare professionals using the BD Veritor System Reader for in vitro diagnostic testing are most at risk. Patients relying on accurate test results from this device may be affected.
Check if your BD Veritor System Reader has the catalog number 256055 and one of the listed serial numbers. The device is used with BD Veritor System Test Kits for in vitro diagnostics.
Verify your device's serial number against the list provided in the recall notice to confirm if it is affected.
The background calibration of the BD Veritor System Reader can cause false positive or false negative test results, potentially leading to misdiagnosis and inappropriate treatment.
Check your device's serial number against the list provided in the recall notice. If it matches, you should stop using it until you can get a replacement or repair.
The recall notice does not specify a fix or remedy for this issue.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-1314-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-1314-2019 from Becton Dickinson. 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.
