Z-0054-2021 Class II Ongoing
FDA device recall Z-0054-2021 was initiated by Luminex Corporation on Dec 10, 2018 and is designated Class II. Reason for recall: No results/incorrect results due to failure of the hybridization heater. The recall status is ongoing. Affected quantity: 1 system.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 14, 2020
- Initiation Date
- Dec 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 system
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.
Distribution Pattern
US distribution in MO. No OUS
Code Information
Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0054-2021
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026