Reported May 31, 2023 · Ongoing

binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria…

Binx Health, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Binx Health, Inc. · 245 1st St Ste 18 · Cambridge, MA · 02142-1292

Is this the product you have?

  • binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis
  • and Neisseria gonorrhoeae Ref1.002.101
Lot codes and dates
  • UDI5060441760050
  • Lot Number00210869309
  • Exp Date
    • March 31
    • 2023
Amount recalled
50 single-use cartridges

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.