Dna Probe, Yeast
FDA adverse event reports and recall history for dna probe, yeast (product code MLA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 190
- Deaths
- 0
- Injuries
- 6
- Malfunctions
- 184
Reports per year
Source: FDA adverse event reports by year received, 2012–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2017-02-27TerminatedEmployee error
BD AffirM VPIII Microbial Identification Test
BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
- 2013-07-26TerminatedUnder Investigation by firm
BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds*** The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,
In vitro diagnostic test kit may exhibit invalid internal negative control results.
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