Binx Health recalls single-use CT/NG assay cartridges that may produce false negative or positive results for chlamydia and gonorrhea detection. Affected units have specific lot numbers and expiration dates.
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
Binx Health is recalling single-use CT/NG assay cartridges that may give false negative or positive results for chlamydia and gonorrhea tests. This could lead to incorrect health diagnoses if used without proper follow-up.
The cartridges may not work properly within their labeled expiration period, potentially causing false negative or positive results for chlamydia and gonorrhea. This could lead to missed infections or unnecessary treatments if not addressed.
People who purchased the Binx io CT/NG Assay cartridges with lot number 00210869309 and expiration date March 31, 2023 are affected. Those using the cartridges for at-home testing may be at risk of incorrect results.
Check for lot number 00210869309 and expiration date March 31, 2023 on the cartridge packaging. The product is sold under the brand Binx Health.
Look for lot number 00210869309 and expiration date March 31, 2023 on the cartridge packaging.
Binx Health is recalling single-use CT/NG assay cartridges that may produce false negative or positive results for chlamydia and gonorrhea detection.
Check for lot number 00210869309 and expiration date March 31, 2023 on the cartridge packaging.
The recall does not specify a remedy, so no action is required beyond checking if you have the affected lot number.
We’ve drafted a message you can send Binx Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1626-2023 — Binx Health Binx Health Hello, I own a Binx Health that is covered by recall Z-1626-2023 from Binx Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
