ARIES SARS-CoV-2 Assay, REF: 50-10047
Reported: November 2, 2022 Initiated: September 14, 2022 #Z-0134-2023
Product Description
ARIES SARS-CoV-2 Assay, REF: 50-10047
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.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 5,141 (24 Cassettes)
- Distribution
- Distribution US nationwide, Indonesia, and Hong Kong.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
ARIES SARS-CoV-2 Assay, REF: 50-10047. Recalled by Luminex Corporation. Units affected: 5,141 (24 Cassettes).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 2, 2022. Severity: Moderate. Recall number: Z-0134-2023.
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