binx io V1 (CT/NG)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060441760050), received between May 2, 2023 and May 2, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Mar 29, 2023Open, Classified

   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

   Z-1626-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Manufacturing, Packaging or Shipping Problem; Output Problem; Manufacturing, Packaging or Shipping Problem; Output Problem

  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.

  Patient problems: Sexually Transmitted Infection

  MAUDE report 16856854 ↗