Helix Elite Molecular Standards: Inactivated Standard recallZ-1371-2025 · 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 A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
FDA root cause category: Process control
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-1371-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 20, 2025
- Posted by the FDA
- Mar 14, 2025
- Recalling firm
- Microbiologics Inc
- Quantity
- 6 units
- Product code
- OHQ
- Distribution
- US Nationwide distribution in the states of TX. UK.
Product description
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0065N
Code information (models, lots, serial numbers)
UDI-DI: 10845357043563; Lot Number: HE0065-29
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 HE0065NMicrobiologics Inc. · Multi-analyte controls unassayed1 recall0 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.
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