BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
Reported: September 25, 2024 Initiated: August 20, 2024 #Z-3184-2024
Product Description
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
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.
Details
- Recalling Firm
- Cypress Medical Products LLC
- Units Affected
- 15 kits
- Distribution
- US Nationwide distribution.
- Location
- Richmond, VA
Frequently Asked Questions
What product was recalled? ▼
BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025. Recalled by Cypress Medical Products LLC. Units affected: 15 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3184-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11