Verigene EP Amplification Reagent Kit Test
Reported: September 22, 2021 Initiated: August 3, 2021 #Z-2451-2021
Product Description
Verigene EP Amplification Reagent Kit Test
Reason for Recall
There is potential for false positive results.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 4579 kits
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Austria, France, Greece, Japan, and Turkey.
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
Verigene EP Amplification Reagent Kit Test. Recalled by Luminex Corporation. Units affected: 4579 kits.
Why was this product recalled? ▼
There is potential for false positive results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 22, 2021. Severity: Moderate. Recall number: Z-2451-2021.
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