Helix Elite Molecular Standards: Inactivated Standard recallZ-1454-2025 · Microbiologics Inc · initiated Feb 20, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The RSV target may give a late Ct value and could potentially not pass QC.
FDA root cause category: Nonconforming Material/Component
What the company is doing
An Urgent Medical Device Recall notification letter dated 2/20/25 was sent to customers. INSTRUCTIONS: 1. REVIEW lab procedures to understand how this information affects your usage 2. DISCARD affected product. 3. COMPLETE the response form provided. 4. RETURN the response form to [email protected] 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns. Collect calls may be made.
Recall details
- Recall number
- Z-1454-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2025
- Posted by the FDA
- Mar 25, 2025
- Recalling firm
- Microbiologics Inc
- Quantity
- 28 units
- Product code
- OHQ
- Distribution
- Worldwide - US Nationwide distribution in the states of KY, MT, NJ, NY, WI and the countries of Ireland, Germany, UK.
Product description
Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte, unassayed quality control material, Catalog Number HE0044N
Code information (models, lots, serial numbers)
UDI-DI: 10845357042184; Lot Number: HE0044-131
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Helix Elite™ Molecular Standards: Inactivated Standard HE0044NMicrobiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page