Z-0920-2022 Class II Ongoing
FDA device recall Z-0920-2022 was initiated by Luminex Corporation on April 22, 2019 and is designated Class II. Reason for recall: Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question. The recall status is ongoing. Affected quantity: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 20, 2022
- Initiation Date
- April 22, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Reason for Recall
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
Distribution Pattern
US: TX, CT, LA
Code Information
Model Number 10-0000-07, Serial Numbers: 13042054,16347082,17215010; Model Number 10-0000-07-R, Serial Numbers: 18079010