Z-1626-2023Class II

binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and...

Name: Z-1626-2023 binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and...
Creator: Binx Health, Inc.
Published: 2023-03-29
License: https://open.fda.gov/license/

Binx Health, Inc. / initiated 2023-03-29 / Open, Classified / root cause: labeling and UDI

FDA source

Binx Health, Inc. began a recall of binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101 on 2023-03-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1626-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-29
Posted: 2023-05-23
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
Product code: QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Reason for recall: 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 tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 50 single-use cartridges
Distribution: In the US state of PA
Product codes and lots: UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1626-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1626-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-23

Product code QEP

K200533Class IIbinx io CT/NG Assay and binx io CT/NG SystemBinx Health, Inc. / cleared 2020-04-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)