QC Sets and Panels: Helix Elite recallZ-1164-2025 · Microbiologics Inc · initiated Jan 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
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded. The concentration of one target (HPV 16 L1) was low enough to cause QC failures, no detection, or invalid results on some instruments and assays.
FDA root cause category: Under Investigation by firm
What the company is doing
Microbiologics issued and Urgent Medical Device Recall notice to its consignees on 01/20/2025 via email. The notice explained the issue and requested the following actions be taken: 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. Please contact our Recall Support team at 320.229.7080 or [email protected] with questions or concerns.
Recall details
- Recall number
- Z-1164-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 20, 2025
- Posted by the FDA
- Feb 12, 2025
- Recalling firm
- Microbiologics Inc
- Quantity
- 27 units
- Product code
- OHQ
- Distribution
- Worldwide distribution - US Nationwide and the countries of Netherlands, Sweden, UK, France, Australia, New Zealand.
Product description
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Code information (models, lots, serial numbers)
UDI/DI 70845357043077, Lot Numbers: 8235-32, 8235-33
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- QC Sets and Panels: Helix Elite™ 8234Microbiologics Inc. · Multi-analyte controls unassayed2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96166).
- Z-1163-2025 · Open, ClassifiedMicrobiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
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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