Helix Elite Molecular Standards: Inactivated Standard recallZ-0699-2022 · Microbiologics Inc · initiated Jun 6, 2017
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
Real-time shelf life testing failed at 24 months
FDA root cause category: Process design
What the company is doing
Microbiologics notified customers on about 06/06/2017 via email containing a letter. The letters indicated the affected products and instructed customers to update their records with the corrected expiration date, which was provided for each affected lot.
Recall details
- Recall number
- Z-0699-2022
- Status
- Terminated
- Initiated by the company
- Jun 6, 2017
- Recalling firm
- Microbiologics Inc
- Quantity
- 1 unit
- Product code
- OHQ
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.
Product description
Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Respiratory Syncytial Virus A Strain Long. Target pathogens are lyophilized in a PCR compatible matrix, and stable at 2C-25C through the expiration date. Each lyophilized pellet is packaged in a single-use foil pouch. Each kit contains 5 unassayed lyophilized pellets, packaged in individual vials for ease-of-use and to avoid cross contamination.
Code information (models, lots, serial numbers)
Catalog Number: HE0028N; Lot Number: HE0028N-102-1; UDI: 10845357042023
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 HE0028NMicrobiologics Inc. · Multi-analyte controls unassayed1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89446).
- Z-0697-2022 · TerminatedMicrobiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: …
- Z-0698-2022 · TerminatedMicrobiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
- Z-0700-2022 · TerminatedHelix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
- Z-0701-2022 · TerminatedHelix Elite" Molecular Standards: Inactivated Standard. Inactivated Influenza A/B and Respiratory Syncytial Virus
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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