FDA-Device2019-08-21Class II
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Luminex Corporation
Hazard
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.
Sold states
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
Affected count
N/A
Manufactured in
12212 Technology Blvd, N/A, Austin, TX, United States
Products
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2286-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief