VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Reported: October 14, 2020 Initiated: December 10, 2018 #Z-0054-2021
Product Description
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Reason for Recall
No results/incorrect results due to failure of the hybridization heater.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 1 system
- Distribution
- US distribution in MO. No OUS
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids. Recalled by Luminex Corporation. Units affected: 1 system.
Why was this product recalled? ▼
No results/incorrect results due to failure of the hybridization heater.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0054-2021.
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