Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Reported: July 13, 2022 Initiated: June 17, 2022 #Z-1334-2022
Product Description
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Reason for Recall
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 296 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
Verigene CDF Nucleic Acid Test, Part No. 30-002-22. Recalled by Luminex Corporation. Units affected: 296 units.
Why was this product recalled? ▼
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1334-2022.
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