Becton Dickinson recalls BD Max instruments (catalog 441916-441927) due to false positive Candida glabrata results when Trichomonas vaginalis is present. Affected units have serial numbers CTI1201-CTI1288.
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
Becton Dickinson is recalling refurbished BD Max instruments with catalog numbers 441916-441927 because they can give false positive Candida glabrata results when a Trichomonas vaginalis test is also positive. This could lead to incorrect diagnoses and treatment decisions.
The BD Max instrument can produce false positive results for Candida glabrata when a Trichomonas vaginalis test is also positive. This means a lab might incorrectly identify Candida glabrata as present when it's not, potentially leading to wrong treatment decisions.
Healthcare professionals using BD Max instruments for lab testing are most at risk. The recall affects refurbished instruments with specific catalog numbers and serial ranges.
Check for catalog numbers 441916 or 441927 on the instrument. Affected units have serial numbers from CTI1201 to CTI1288. These are refurbished instruments used in clinical labs.
Identify the catalog number and serial number on your BD Max instrument to confirm if it's affected.
The BD Max instrument can give false positive Candida glabrata results when a Trichomonas vaginalis test is also positive, which could lead to incorrect diagnoses.
Check the catalog number and serial number to see if it's affected. If it is, contact Becton Dickinson for further instructions.
This recall is for potential false positive results, not a physical safety hazard. The risk is low and only affects specific test results.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0313-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0313-2019 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.
