FDA Medical Device Recalls (openFDA)
Microbiologics Inc: Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
- Recall number
- Z-0700-2022
- Recalling firm
- Microbiologics Inc
- Product
- Helix Elite" Molecular Standards: Inactivated Standard. Inactivated Neisseria gonorrhoeae Strain GL0071.
- Status
- Terminated
- Initiated
- 2017-06-06
- Posted
- not on file
- Terminated
- 2023-01-17
- Reason
- Real-time shelf life testing failed at 24 months
- Root cause
- Process design
- Action
- 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.
- Quantity
- 1
- 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.
- Lot, serial or model codes
- Catalog Number: HE0041N; Lot Number: HE0041N-102-1; UDI: 10845357042153
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHQ
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28