Diagnostic Cartridge Assay May Fail to Detect Chlamydia Trachomatis Correctly
Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The diagnostic defect poses a risk of harm through false negative or false positive results in STI detection, but no actual harm has been reported, meeting the criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Binx Health, Inc. is recalling a single lot of binx io CT/NG Assay cartridges (Lot 00210869309, expiration March 31, 2023) distributed in Pennsylvania. These are single-use diagnostic cartridges intended for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae.
The affected cartridges may not meet their declared performance characteristics for detecting Chlamydia trachomatis within the labeled expiry period. The potential defect could result in false negative results, where an actual infection is not detected, or false positive results, where an infection is incorrectly indicated when none is present.
The recalled cartridges were distributed only within Pennsylvania. Users with cartridges from this lot (00210869309) should consult with Binx Health regarding appropriate next steps.
The recalled product
- Product
- binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
- Manufacturer
- Binx Health, Inc.
- Hazard
- false-negative
- false-positive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31
- 2023
Distribution
Distributed in 1 state:
- PA
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