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U.S. Department of Health and Human Services

Class 2 Device Recall ARIES Bordetella Assay

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  Class 2 Device Recall ARIES Bordetella Assay see related information
Date Initiated by Firm February 20, 2019
Date Posted August 15, 2019
Recall Status1 Open3, Classified
Recall Number Z-2282-2019
Recall Event ID 83470
510(K)Number K163626  
Product Classification Bordetella pertussis dna assay system - Product Code OZZ
Product Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Code Information Lot numbers and discontinue use by date for Part Number 50-10037: AA7125 - Immediately, AA7310 - Immediately, AA7548 - 3/13/2019, AA7633 - 4/12/2019
Recalling Firm/
Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact
512-219-8020 Ext. 202
Manufacturer 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.
FDA Determined
Cause 2
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) support@luminexcorp.com 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OZZ and Original Applicant = Luminex Corporation