FDA Medical Device Recalls (openFDA)
Binx Health, Inc.: binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
- Recall number
- Z-1626-2023
- Recalling firm
- Binx Health, Inc.
- Product
- binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
- Status
- Open, Classified
- Initiated
- 2023-03-29
- Posted
- 2023-05-23
- Terminated
- not on file
- Reason
- May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results
- Root cause
- Under Investigation by firm
- Action
- Binx issued Urgent Medical Device Recall Letter on 29 March 2023 via email. On 31 March 2023 a hard copy of the written Recall Notification and Response Form was sent via certified mail through the United States Postal Service. Letter states reason for recall, health risk and action to take: Discontinue use of the binx io CT/NG Assay lot listed above, and discard your inventory of this lot. " At the Clinic Director s discretion results may be reviewed. RESOLUTION: " binx health has removed this binx io CT/NG Assay lot from our inventory. We will provide alternate lots for all current and future replenishment orders or requests. Please share this information with your clinic staff and retain this notification as part of your clinic Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory or clinic, please provide them a copy of this letter. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. If you have any questions regarding this notice, please contact the binx Quality Assurance department by email at qateam@mybinxhealth.com.
- Quantity
- 50 single-use cartridges
- Distribution
- In the US state of PA
- Lot, serial or model codes
- UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023
- 510(k) numbers
- ["K200533"]
- PMA numbers
- not on file
- Product code
- QEP
- Firm FEI
- 3017812966
- Firm city
- Cambridge
- Firm state
- MA
- 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