Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Reported: May 25, 2022 Initiated: April 5, 2022 #Z-1092-2022
Product Description
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Reason for Recall
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 24 units
- Distribution
- US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system. Recalled by Luminex Corporation. Units affected: 24 units.
Why was this product recalled? ▼
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1092-2022.
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