Luminex Corporation: Medical Device Recall in 2019 - (Recall #: Z-2288-2019)

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 Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

Product Classification:

Class II

Date Initiated: February 20, 2019

Date Posted: August 21, 2019

Recall Number: Z-2288-2019

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 50-10026: AA7126 Immediately AA7307 - Immediately AA7385 - Immediately AA7525 - 3/1/2019 AA7547 - 3/16/2019 AA7628 - 4/12/2019 AA7666 - 3/28/2019

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