Recall Z-0920-2022— Luminex Corporation
Class II · Ongoing
Class II FDA medical device recall by Luminex Corporation, initiated 2019-04-22. FDA's recall record names no specific 510(k) clearance for this event. Product: Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R. Reason: Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question..
- Recalling firm
- Luminex Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-04-22
- Firm location
- Northbrook, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.