FDAClass IIAugust 14, 2024

Verigene Gram Positive Blood Culture recall

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

Why was Verigene Gram Positive Blood Culture recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024

Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Recalling firm
Luminex Corporation
Quantity
1,100 kits
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.
Recall date
August 14, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls