Recall Z-1626-2023— Binx Health, Inc.
Class II · Ongoing
Class II FDA medical device recall by Binx Health, Inc., initiated 2023-03-29. It names one FDA 510(k) clearance: K200533. 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.
- Recalling firm
- Binx Health, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-29
- Firm location
- Cambridge, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.