Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Reported: April 2, 2025 Initiated: February 20, 2025 #Z-1454-2025
Product Description
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Reason for Recall
The RSV target may give a late Ct value and could potentially not pass QC.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 28 units
- Distribution
- Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N. Recalled by Microbiologics Inc. Units affected: 28 units.
Why was this product recalled? ▼
The RSV target may give a late Ct value and could potentially not pass QC.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 2, 2025. Severity: Moderate. Recall number: Z-1454-2025.
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