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U.S. Department of Health and Human Services

Class 2 Device Recall binx io CT/NG Assay

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  Class 2 Device Recall binx io CT/NG Assay see related information
Date Initiated by Firm March 29, 2023
Date Posted May 23, 2023
Recall Status1 Open3, Classified
Recall Number Z-1626-2023
Recall Event ID 92143
510(K)Number K200533  
Product Classification Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections - Product Code QEP
Product binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae

Ref: 1.002.101
Code Information UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023
Recalling Firm/
Manufacturer		 Binx Health, Inc.
245 1st St Ste 18
Riverview II
Cambridge MA 02142-1292
For Additional Information Contact Ms. Sarah Thomas
610-504-6644
Manufacturer 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
FDA Determined
Cause 2		 Under Investigation by firm
Action Binx issued Urgent Medical Device Recall Letter on 29 March 2023 via email. On 31 March 2023 a hard copy of the written Recall Notification and Response Form was sent via certified mail through the United States Postal Service. Letter states reason for recall, health risk and action to take: Discontinue use of the binx io CT/NG Assay lot listed above, and discard your inventory of this lot. " At the Clinic Director s discretion results may be reviewed. RESOLUTION: " binx health has removed this binx io CT/NG Assay lot from our inventory. We will provide alternate lots for all current and future replenishment orders or requests. Please share this information with your clinic staff and retain this notification as part of your clinic Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory or clinic, please provide them a copy of this letter. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication. If you have any questions regarding this notice, please contact the binx Quality Assurance department by email at qateam@mybinxhealth.com.
Quantity in Commerce 50 single-use cartridges
Distribution In the US state of PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = QEP and Original Applicant = binx health Inc
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