Becton Dickinson recalls BD Max Instrument Reader spare parts (serial numbers 079577-079896, etc.) due to false positive Candida glabrata results when Trichomonas vaginalis is present. Affected users should contact for remedy.
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 spare parts for their BD Max Instrument Reader because they can cause false positive Candida glabrata test results when Trichomonas vaginalis is also positive. This could lead to incorrect diagnoses if the test is used in medical settings.
The spare part can cause false positive results for Candida glabrata when a Trichomonas vaginalis test is also positive. This means the test might incorrectly indicate Candida glabrata is present when it isn't, leading to potential misdiagnosis.
Users of the BD Max Instrument Reader in clinical or research settings who have the specific spare parts with the listed serial numbers are affected. Healthcare professionals and labs using these parts for Candida testing are most at risk.
Check if your BD Max Instrument Reader spare part has a serial number from the list: 079577 to 079896, 78154, 78503, 78363, and other numbers listed in the recall notice.
Verify if your spare part has a serial number from the list: 079577 to 079896, 78154, 78503, 78363, and other numbers provided in the recall.
The spare part can cause false positive Candida glabrata results when a Trichomonas vaginalis test is also positive, which may lead to incorrect diagnoses.
No, the recall does not require stopping use immediately. The hazard is low risk and only affects specific test results.
Check the serial number on the spare part against the list provided in the recall notice: 079577 to 079896, 78154, 78503, 78363, and other numbers listed.
We’ve drafted a message you can send Becton Dickinson to request your refund or repair — edit it as you like.
Subject: Recall Z-0312-2019 — Becton Dickinson Becton Dickinson Hello, I own a Becton Dickinson that is covered by recall Z-0312-2019 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.
