Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed qu
Summary
The FDA issued a Class II for Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Sync by Microbiologics Inc. Reason: The RSV target may give a late Ct value and could potentially not pass QC..
Details
Source
Device Recall
External ID
Z-1454-2025
Action Date
2025-04-02
Status
Ongoing
Category
device
Product Description
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Lot/Code Info: UDI-DI: 10845357042184; Lot Number: HE0044-131
Quantity Affected: 28 units
Reason for Recall
The RSV target may give a late Ct value and could potentially not pass QC.
Distribution
Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-20
Company
Saint Cloud, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 216 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microbiologics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microbiologics Inc have FDA actions?
Microbiologics Inc has 52 FDA actions in our database, including 52 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1454-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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