FDA (Devices) recall action 93125
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
The agency’s own wording, quoted from the enforcement report.
Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.
Cepheid is recalling 1,413 Xpert Xpress Strep A test kits due to a defect in the included pipettes. Defective pipettes may fail to dispense adequate sample volume, resulting in invalid test results or no test result.