Recall Z-1626-2023 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
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
| Date | May 23, 2023 (initiated Mar 29, 2023) |
| Status | Open, Classified |
| 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 futu |
| Quantity | 50 single-use cartridges |
| Distribution | In the US state of PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200533 | binx io CT/NG Assay and binx io CT/NG System Binx Health, Inc., Apr 27, 2020 |