Home / Recalls / Luminex Corporation / Z-1524-2022

Z-1524-2022 Class II Ongoing

Recalled by Luminex Corporation — Austin, TX

Recall Details

Product Type
Devices
Report Date
August 24, 2022
Initiation Date
July 14, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
257

Product Description

ARIES SARS-CoV-2 Assay

Reason for Recall

SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N genes may not detect the ORF1ab gene. A positive results if either SARS-CoV-2 genes is detected, but If both genes are mistakenly not detected, a false negative result would be generated.

Distribution Pattern

U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.

Code Information

Lot: AB4042A

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  • Z-0500-2024 Class II — Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Cultur (November 7, 2023)
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  • Z-1334-2022 Class II — Verigene CDF Nucleic Acid Test, Part No. 30-002-22 (June 17, 2022)
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  • Z-1109-2022 Class II — VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021 (February 15, 2022)