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

FDA device recall Z-1626-2023 · posted 2023-05-23 · Open, Classified

Recall details

Recalling firm

Binx Health, Inc.

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QEP

Quantity affected

50 single-use cartridges

Distribution

In the US state of PA

Date initiated

2023-03-29

Date posted

2023-05-23

Location

Cambridge, MA

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