Luminex Corporation: Medical Device Recall in 2019 - (Recall #: Z-2285-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 20, 2019

Date Posted: August 21, 2019

Recall Number: Z-2285-2019

Event ID: 83470

Reason for Recall:

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.

Status: Ongoing

Product Quantity: N/A

Code Information:

Lot numbers & discontinue use by dates for part number 50-10021: AA7546 - 3/9/2019 AA7629 - 4/10/2019

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

Voluntary or Mandated:

Voluntary: Firm initiated