Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Reported: July 14, 2021 Initiated: October 30, 2020 #Z-2008-2021
Product Description
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Reason for Recall
Potential for a false-negative result.
Details
- Recalling Firm
- Luminex Corporation
- Units Affected
- 17,110
- Distribution
- Worldwide distribution - US Nationwide including in the states of AL, AZ, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA and VT. The countries of Austria, Chile, France, Germany, Greece, Italy, Japan, Kuwait, Netherlands, Spain, Thailand, Turkey, and United Kingdom.
- Location
- Northbrook, IL
Frequently Asked Questions
What product was recalled? ▼
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021. Recalled by Luminex Corporation. Units affected: 17,110.
Why was this product recalled? ▼
Potential for a false-negative result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2008-2021.
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