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U.S. Department of Health and Human Services

Class 2 Device Recall Luminex' ARIES SARSCoV2 Assay

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 Class 2 Device Recall Luminex' ARIES SARSCoV2 Assaysee related information
Date Initiated by FirmSeptember 14, 2022
Date PostedOctober 26, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0134-2023
Recall Event ID 90937
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
ProductARIES SARS-CoV-2 Assay, REF: 50-10047
Code Information Lot - Expiration: AB4723A - 05/25/2022, AB5041A - 05/25/2022, AB5060A - 06/01/2022, AB5061A - 06/06/2022, AB5081A - 06/07/2022, AB5139A - 09/10/2022, AB5141A - 09/16/2022, AB5263A - 09/27/2022, AB5282A - 10/05/2022, AB6640A - 06/8/2023, AB6720A - 06/13/2023
Recalling Firm/
Manufacturer		 Luminex Corporation
12212 Technology Blvd
Austin TX 78727-6101
For Additional Information Contact
512-219-8020
Manufacturer Reason
for Recall		A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result.
FDA Determined
Cause 2		Packaging process control
ActionOn 09/14/22, recall notices were emailed to customers who were asked to do the following: 1. Cease all use, and isolate or quarantine affected devices pending disposal. 2. If affected devices are identified, contact the recalling firm at support@luminexcorp.com to arrange for replacement and confirm the disposal of any remaining kits in your inventory per the package insert disposal guidelines. 3. Perform a retrospective review of results obtained using the affected SARS-CoV-2 Assay. If you suspect that you have encountered a false negative result with a patient sample, please contact the recalling firm at support@luminexcorp.com. 4. Distribute the notification to any individuals within your organization who need to be made aware of this recall. 5. If affected devices were further distributed, notify your customers of this recall. 6. Please complete and return the Acknowledgement & Receipt Form. 7. For those with complaints, questions, or concerns, please contact Global Technical Support Services at 1-877-785-2323 (U.S. and Canada) or +1-512-381 -4397 (Outside U.S. and Canada). On 12/05/22, additional recall notices were sent to customers notifying them that two additional lots were impacted.
Quantity in Commerce5,141 (24 Cassettes)
DistributionDistribution US nationwide, Indonesia, and Hong Kong.
Total Product Life CycleTPLC 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.
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