ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

Reason: 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.

Code information: Lot numbers & discontinue use by dates for Part Number 50-10041: AA7313 - Immediately; AA7526 - 3/7/2019; AA7605 - 3/9/2019; AA7631 - 4/3/2019; AA7645 - 4/12/2019

Distribution pattern: 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