Z-2287-2019Class II

ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

Name: Z-2287-2019 ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Creator: Luminex Corporation
Published: 2019-02-20
License: https://open.fda.gov/license/

Luminex Corporation / initiated 2019-02-20 / Open, Classified / root cause: manufacturing process

FDA source

Luminex Corporation began a recall of ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059 on 2019-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2287-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-20
Posted: 2019-08-15
Recalling firm: Luminex Corporation
Product: ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Product code: OZN C. Difficile Toxin Gene Amplification Assay
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 20, 2019, the firm sent a "Urgent: Medical Device Recall/Field Safety Notice" via email to all consignees. The customer notification informed customers of the following: 1. As an immediate action, Luminex is requesting that customers discontinue use of and discard the products listedin the recall notice immediately or by the Discontinue Use By date. Contact Luminex Global Support Services to obtain replacement material. Material that is still within its Discontinue Use By date may be used at the customers discretion. 2. Complete the Acknowledgment and Receipt form. You must complete and return this form even if you do not have any remaining product. Luminex Technical Support can assist you in completing this form. This information is essential in order to maintain recall effectiveness information required by US FDA. 3. Although no adverse events have been reported, adverse reaction or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 4. Please call the Luminex Global Support Services Team if you have any questions or concerns. Luminex Global Support Services 1-877-785-2323 (U.S. and Canada) +1-512-381-4397 (Outside U.S. and Canada) [email protected] CAN-0233
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2287-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2282-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-21	2019-08-15
Z-2283-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-21	2019-08-15
Z-2284-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-21	2019-08-15
Z-2285-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-21	2019-08-15
Z-2286-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-21	2019-08-15
Z-2287-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-21	2019-08-15
Z-2288-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-21	2019-08-15

Product code OZN

K171441Class IIARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension KitLuminex Corporation / cleared 2017-07-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)