Z-1626-2023 Class II Ongoing
FDA device recall Z-1626-2023 was initiated by Binx Health, Inc. on March 29, 2023 and is designated Class II. 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 res… The recall status is ongoing. Affected quantity: 50 single-use cartridges.
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2023
- Initiation Date
- March 29, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 single-use cartridges
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
Distribution Pattern
In the US state of PA
Code Information
UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023