Luminex Corporation: Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

Hazard

Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.

Details from the source

Reason for recall: Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets. 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. Quantity: 1,100 kits Lot/code info: GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024

UPC codes

00840487101575

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.