Helix Elite Molecular Standards: Inactivated Standard recallZ-0955-2022 · Microbiologics Inc · initiated Mar 22, 2022
Terminated
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 QC process was not adequate for the specification range.
FDA root cause category: Process control
What the company is doing
A customer letter, dated 03/24/2022, was issued to the impacted consignee via email. The consignee is instructed to destroy the product as it is now past its updated expiration date. The consignee is asked to complete the response form and submit to the recalling firm.
Recall details
- Recall number
- Z-0955-2022
- Status
- Terminated
- Initiated by the company
- Mar 22, 2022
- Recalling firm
- Microbiologics Inc
- Quantity
- 2 ea
- Product code
- OHQ
- Distribution
- US Nationwide distribution in the states of NV and VT.
Product description
Inactivated macrolide-resistant Mycoplasma genitalium
Code information (models, lots, serial numbers)
Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
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 HE0070NMicrobiologics 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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