binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoe
Summary
The FDA issued a Class II for binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlam by Binx Health, Inc.. Reason: May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to p.
Details
Source
Device Recall
External ID
Z-1626-2023
Action Date
2023-05-31
Status
Ongoing
Category
device
Product Description
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Lot/Code Info: UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023
Quantity Affected: 50 single-use cartridges
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
Distribution
In the US state of PA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-29
Company
Cambridge, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Binx Health, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Binx Health, Inc. have FDA actions?
This is the only FDA action we have on record for Binx Health, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1626-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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