BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Summary
The FDA issued a Class II for BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025 by Cypress Medical Products LLC. Reason: Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite lice.
Details
Source
Device Recall
External ID
Z-3184-2024
Action Date
2024-09-25
Status
Ongoing
Category
device
Product Description
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Lot/Code Info: GTIN: 10811877010453; All Lots
Quantity Affected: 15 kits
Reason for Recall
Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-20
Company
Richmond, VA
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 257 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cypress Medical Products LLC has 5 FDA actions in our database, including 5 recalls.
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 (Cypress Medical Products LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cypress Medical Products LLC have FDA actions?
Cypress Medical Products LLC has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3184-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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