Luminex Corporation recalls ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

Recall date

February 20, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2285-2019

FDA classification

Class II

Brand / firm

Luminex Corporation

Sold / distributed

US: AK, AL, AZ,CA,CO,FL,GA,IL,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,NE,NJ,NM,NY,OH,ON,OR,PA,TN,TX,UT,VA,VT,WA,WI, OUS: Belgium, Canada, Thailand, Germany, Singapore, United Kingdom

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARIES GBS Assay , REF 50-10021, UDI # 00840487100165