Houston lab identifies manufacturing defects in DNA cartridge tests; notifies prosecutors

The Houston Forensic Science Center (HFSC) told its board that laboratory staff discovered manufacturing defects in QIAGEN DNA investigator cartridges that can produce low or no DNA recovery and potentially false-negative results in some samples.

The finding was disclosed during HFSC’s board meeting by President and CEO Dr. Peter Stout. He said the primary problem is an incorrect pH in one reagent position in occasional cartridges, which can yield low DNA recovery. “That profile could be potentially exonerating,” Stout said, describing the risk if a true DNA profile is missed. He added later, “So your reward for finding this is the cost and agony of having to fix it. Yep. That's our reward for it.”

HFSC staff, working with commercial partner Signature Science, traced the issue to specific reagent lots and halted use of affected lots while they investigated. Signature Science ran hundreds of comparative tests and HFSC reviewed 15 years of internal quality-control data. The lab said most historical results prior to the flagged timeframe remain supported by internal checks. HFSC focused notifications on a manufacturing window it considers higher risk and has informed Harris County…