FDA Medical Device Recalls (openFDA)
Microbiologics Inc: Inactivated macrolide-resistant Mycoplasma genitalium
- Recall number
- Z-0955-2022
- Recalling firm
- Microbiologics Inc
- Product
- Inactivated macrolide-resistant Mycoplasma genitalium
- Status
- Terminated
- Initiated
- 2022-03-22
- Posted
- not on file
- Terminated
- 2023-01-09
- Reason
- The QC process was not adequate for the specification range.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 2 ea
- Distribution
- US Nationwide distribution in the states of NV and VT.
- Lot, serial or model codes
- Catalog # HE0070N; Lot HE0070-01-1 UDI: 10845357044003
- 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