ARIES SARS-CoV-2 Assay
Reported: August 24, 2022 Initiated: July 14, 2022 #Z-1524-2022
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.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 257
- Distribution
- U.S. Nationwide distribution in the states of NE, TX, MS, TN, KY, ME, CA.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
ARIES SARS-CoV-2 Assay. Recalled by Luminex Corporation. Units affected: 257.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2022. Severity: Moderate. Recall number: Z-1524-2022.
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