MAUDE Adverse Event Report: BINX HEALTH LTD. BINX IO CT/NG ASSAY

Model Number	1.002.101
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Output Problem (3005)
Health Effect - Clinical Code	Sexually Transmitted Infection (4555)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The binx io ct/ng cartridge, when tested using the binx io instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of chlamydia trachomatis (ct) and neisseria gonorrhoeae (ng) dna by polymerase chain reaction.Lot 00210869309 of the binx io ct/ng cartridges failed its finished product quality control (qc) testing.Lot 00210869309 was quarantined on 13 july 2022 and no devices from this lot were to be distributed to customers.Lot 00210869309 was intended for internal use only by binx health field service employees for performing test assessments.A processing error by a third-party logistics provider meant that one box of lot 00210869309 product was inadvertently allocated to a customer order and shipped to a single site on 09 february 2023.One box equals fifty ct/ng cartridges.The processing error was identified during an internal inventory reconciliation on 14 march 2023.Information regarding patient outcomes based on patient samples run using the ct/ng cartridges from lot 00210869309 has not been shared with binx health at this time.

• Brand Name: BINX IO CT/NG ASSAY
• Common Device Name: CT/NG ASSAY
• Manufacturer (Section D): BINX HEALTH LTD.; derby court, epsom square; white horse business park; trowbridge, BA14 0XG; UK BA14 0XG
• Manufacturer (Section G): BINX HEALTH, LTD.; derby court, epsom square; white horse business park; trowbridge, BA14 OXG; UK BA14 OXG
• Manufacturer Contact: suzy korreck ; 245 first street; riverview ii, 18th floor; cambridge, MA 02142 ; 6086580811
• MDR Report Key: 16856854
• Report Number: 3017907743-2023-00001
• Device Sequence Number: 19690359
• Product Code: QEP
• UDI-Device Identifier: 05060441760050
• UDI-Public: 5060441760050
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K200533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1.002.101
• Device Lot Number: 00210869309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3017812966-3/29/23-001-R
• Patient Sequence Number: 1
• Patient Sex: Unknown