FDA Device recall Z-1626-2023
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
- FDA Device
- Class II
- ongoing
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101 by Binx Health, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1626-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-29 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Binx Health |
| Distribution | PA |
Product
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
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
Identifiers
| code_info | UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1626-2023%22
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