Lower risk Medical device recall · FDA · Published February 20, 2019

Luminex ARIES HSV 1&2 Assay Recall: Partial Seal Risk

Luminex recalls ARIES HSV 1&2 Assay (REF 50-10017) due to potential partial sealing of side cassette assemblies, which may decrease solution volume and assay sensitivity. Affected units include specific lot numbers with discontinuation dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2283-2019Medical device Luminex ›

Lower-risk 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.

Take action

Contact the company

Recalling firmLuminex Corporation12212 Technology Blvd · Austin, TX 78727-6101

✎ GovInfoNow plain-language explainer

Luminex is recalling its ARIES HSV 1&2 Assay (REF 50-10017) because some side cassette assemblies have a partial seal that could reduce solution volume and make the assay less sensitive. This recall affects specific lot numbers with different discontinuation dates. Read more at govinfonow.com/recall/68972-luminex-aries-hsv-1-2-assay-recall-partial-seal-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/68972-luminex-aries-hsv-1-2-assay-recall-partial-seal-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2283-2019

Cite this page

“Luminex ARIES HSV 1&2 Assay Recall: Partial Seal Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68972-luminex-aries-hsv-1-2-assay-recall-partial-seal-risk. Based on FDA recall #Z-2283-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2283-2019%22&limit=1).

The FDA announced on Feb. 20, 2019, that Luminex Corporation voluntarily recalled the ARIES HSV 1&2 Assay due to partially sealed side cassette assemblies that could decrease assay sensitivity or stability. The agency issued recall number Z-2283-2019 for the device.

How to tell if you have it

Brand: Luminex
Product: ARIES HSV 1&2 Assay
REF: 50-10017
UDI: 00840487100295
Lot AA7308 - Immediately
Lot AA7485 - 2/23/2019
Lot AA7545 - 3/13/2019
Lot AA7625 - 4/10/2019
Lot AA7630 - 3/16/2019
Lot AA7636 - 4/3/2019
Lot AA7945 - 4/25/2019
Lot AA7985 - 5/8/2019

The hazard

GovInfoNow's records show that a portion of side cassette assemblies had back side seals that did not meet design specifications. This defect could result in a decrease in solution volume and decreased sensitivity or stability of the assay.

Context

Luminex Corporation has 22 other recalls on record since 2018-05-08. Other recent recalls of similar products include Luminex VERIGENE Gram Negative Blood Culture Test Recall (2025-04-16), Luminex Verigene Gram Positive Blood Culture Test Recall (2024-06-20), and Luminex VERIGENE BC-GP Utility Tray Recall (2023-11-07). Other recent recalls of similar products include Siemens Healthcare Syva Emit Disopyramide Assay Recall (2026-06-26), AVID Medical Halyard IV Start Kit Recall (2026-07-22), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13).

How to tell if you have this one

Check the lot number on the product label. Affected lots are AA7308, AA7485, AA7545, AA7625, AA7630, AA7636, AA7945, and AA7985. Discontinue use by the dates listed for each lot.

Brand
Luminex
Category
Medical device

FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
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

Recall number	Product, codes & lots
Z-2282-2019	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
Z-2283-2019	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
Z-2284-2019	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
Z-2285-2019	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
Z-2286-2019	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
Z-2287-2019	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
Z-2288-2019	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

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Identify the lot number on the product label to determine if it is affected.
Discontinue Use
Stop using the affected lot numbers by the specified discontinuation dates.

Where it went and when

Where it was distributed

Distributed in 34 states, and outside the U.S.

FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 6 months after the firm started it.

Feb 20, 2019Firm started the recall
Aug 15, 2019FDA classified it Class II
Aug 21, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/68972-luminex-aries-hsv-1-2-assay-recall-partial-seal-risk">Luminex ARIES HSV 1&amp;2 Assay Recall: Partial Seal Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2283-2019 (February 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2283-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.