| Class 2 Device Recall ARIES GBS Assay | |
Date Initiated by Firm | February 20, 2019 |
Date Posted | August 15, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2285-2019 |
Recall Event ID |
83470 |
510(K)Number | K162772 |
Product Classification |
Nucleic acid amplification assay system, group b streptococcus, direct specimen test - Product Code NJR
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Product | ARIES GBS Assay , REF 50-10021, UDI # 00840487100165 |
Code Information |
Lot numbers & discontinue use by dates for part number 50-10021: AA7546 - 3/9/2019 AA7629 - 4/10/2019 |
Recalling Firm/ Manufacturer |
Luminex Corporation 12212 Technology Blvd Austin TX 78727-6101
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = NJR
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