Z-2007-2021 Class II Ongoing
FDA device recall Z-2007-2021 was initiated by Luminex Corporation on October 30, 2020 and is designated Class II. Reason for recall: Potential for a false-negative result. The recall status is ongoing. Affected quantity: 36,416.
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- October 30, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36,416
Product Description
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Reason for Recall
Potential for a false-negative result.
Distribution Pattern
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.
Code Information
030620018A, 031420018A, 032020018A, 040120018A, 041020018B, 041720018B, 042420018A, 043020018A, 050220018A, 050720018A, 050920018A, 051320018A, 051420018A, 051520018A, 052020018A,052120018A, 052920018A, 060220018A, 060920018A, 061020018A, 061620018A, 061920018D, 062020018A, 062620018A, 063020018A, 070720018A, 071620018A, 072320018A, 073020018A, 080520018A, 082020018A, 082520018A, 082820018A, and 090120018A