VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

Reason: It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

Code information: UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025

Distribution pattern: US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.