Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Reported: August 14, 2024 Initiated: June 20, 2024 #Z-2533-2024
Product Description
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Reason for Recall
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 1,100 kits
- Distribution
- US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test. Recalled by Luminex Corporation. Units affected: 1,100 kits.
Why was this product recalled? ▼
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2024. Severity: Moderate. Recall number: Z-2533-2024.
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