Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Device

Luminex Corporation: 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.

Agency Publication Date: August 15, 2019
Share:
Sign in to monitor this recall

Affected Products

Product: Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

Lot numbers and discontinue use by date for Part Number 50-10037: AA7125 - Immediately, AA7310 - Immediately, AA7548 - 3/13/2019, AA7633 - 4/12/2019

Lot Numbers:
numbers
Product: ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

Lot numbers & discontinue use by dates for Part Number 50-10017: AA7308 - Immediately; AA7485 - 2/23/2019; AA7545 - 3/13/2019; AA7625 - 4/10/2019; AA7630 - 3/16/2019; AA7636 - 4/3/2019; AA7945 - 4/25/2019; AA7985 - 5/8/2019

Lot Numbers:
numbers
Product: ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

Lot numbers and discontinue use by dates for Part Number 50-10020: AA7127 - Immediately; AA7206 - Immediately; AA7312 - 3/5/2019; AA7549 - 3/30/2019; AA7635 - 4/10/2019

Lot Numbers:
numbers
Product: ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

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

Lot Numbers:
numbers
Product: ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

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

Lot Numbers:
numbers
Product: ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

Lot numbers & discontinue use by dates for Part Number 50-10018 AA7306 - Immediately; AA7311 - 2/27/2019; AA7627 - 3/28/2019; AA7634 - 4/3/2019

Lot Numbers:
numbers
Product: ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

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

Lot Numbers:
numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83470
Status: Active
Manufacturer: Luminex Corporation
Manufactured In: United States
Agency Last Updated: September 20, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.