binx io CT/NG Assay- Single-use Cartridge for the qualitative… — Class II medical device recall Z-1626-2023
Ongoing recall by Binx Health, Inc., reported 2023-05-31. May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within t
| Recall number | Z-1626-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Binx Health, Inc., Cambridge, MA, United States |
| Recall initiated | 2023-03-29 |
| Classified | 2023-05-23 |
| Reported by FDA | 2023-05-31 |
| Quantity | 50 single |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 05060441760050 |
| Lot numbers | 00210869309 |
| Model numbers | 1.002.101 |
| Expiration dates | 2023-03-31 |
Product
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1626-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.