FDA (Devices) recall action 83470
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Through internal investigation, it was discovered that a portion of side cassette assemblies (SCAs) back side seal (BSS) did not meet design specification, resulting in partially sealed SCAs. The impact of a partial seal of the BSS could result in potential decrease of volume for each solution in the SCAs and decreased sensitivity or stability of the assay.
The agency’s own wording, quoted from the enforcement report.
Luminex Corporation is recalling ARIES GBS Assay kits because partially sealed side cassettes may cause decreased assay sensitivity or stability.
Luminex is recalling ARIES HSV 1&2 Assay kits because side cassette seals did not meet specifications, potentially affecting test sensitivity and stability.
Luminex is recalling ARIES Group A Strep Assay kits because side cassette seals may not meet specifications, potentially affecting test sensitivity and stability.
Luminex is recalling ARIES C. difficile Assay kits because defective side cassette seals may reduce assay sensitivity and stability.
Luminex Corporation is recalling Aries Bordetella Assay kits because partially sealed side cassette assemblies may reduce assay sensitivity or stability.
Luminex is recalling ARIES Flu A/B & RSV Assay kits because a seal defect may reduce assay sensitivity or stability.
Luminex Corporation is recalling ARIES Extraction Kits because partially sealed side cassette assemblies may reduce assay sensitivity and stability.