Z-2533-2024 Class II Ongoing
FDA device recall Z-2533-2024 was initiated by Luminex Corporation on June 20, 2024 and is designated Class II. Reason for recall: Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. The recall status is ongoing. Affected quantity: 1,100 kits.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- June 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,100 kits
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.
Distribution Pattern
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.
Code Information
GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024