medical Class II Updated 2019-08-21

Luminex Corporation recalls ARIES Group A Strep Assay , REF 50-10041, UDI # 008404871014

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: 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, OR, PA, TN, TX, UT, VA, VT, WA, WI

Lot/Code Info: 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

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