Helix Elite Molecular Standards: Inactivated Standard recallZ-1740-2022 · Microbiologics Inc · initiated Jul 27, 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
Product not registered for use in the UK
FDA root cause category: Process control
What the company is doing
Microbiologics initially contacted the consignee via email on 07/27/2022. A formal letter was provided via email on 08/15/2022. The notification instructed the consignee to review lab procedures to understand how the recall affects their usage, discard any units depending on the lab procedures, complete and return the response form, maintain the recall letter for record, and contact Microbiologics for replacement if needed.
Recall details
- Recall number
- Z-1740-2022
- Status
- Terminated
- Initiated by the company
- Jul 27, 2022
- Posted by the FDA
- Sep 14, 2022
- Recalling firm
- Microbiologics Inc
- Quantity
- 2
- Product code
- OHQ
- Distribution
- International distribution to the country of United Kingdom.
Product description
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Code information (models, lots, serial numbers)
a. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Helix Elite™ Molecular Standards: Inactivated Standard HE0071NMicrobiologics Inc. · Multi-Analyte Controls Unassayed1 recall0 reports
- Helix Elite™ Molecular Standards: Inactivated Standard HE0073NMicrobiologics 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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