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State labs flag QIAGEN cartridge problems after spike in low/no-DNA results; vendor quality process under review
Summary
Houston and other Texas labs reported an uptick in low or no DNA recoveries from QIAGEN easy-platform cartridges. The commission heard presentations from Houston Forensic Science Center staff and others describing the investigation, vendor communications, and recommended QC and reporting changes.
Houston Forensic Science Center (HFSC) staff and other Texas laboratories briefed the commission on a manufacturing-quality issue affecting QIAGEN Easy-system cartridges that produced a higher-than-expected rate of low or no DNA recovery in some lots.
HFSC representatives described a cluster of unintuitive negative or low-yield results beginning in mid-2024 and a marked increase in failures in a specific lot group (identified in staff materials as "lot F" among several lots examined). HFSC reported that between November 2022 and May 2024 the unintuitive-negative rate was about 2.8 percent in their test population, but from June to August 2024 the rate rose to about 14 percent for samples HFSC sent for external processing. HFSC92s blind-quality-control program helped identify the issue.
HFSC staff said they performed broad retesting (including 340 samples…
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