Device product
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Z-1626-2023
Product summary
- Event
- Event 92143
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 single-use cartridges
- Official record key
device-enforcement:Z-1626-2023
Official wording
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
Code information: UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023
Distribution pattern: In the US state of PA
Derived failure modes
-
Unknown
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