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Recall Observatory FDA recall evidence

Device product

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

Z-2533-2024

June 20, 2024

Class II

Product summary

Firm
Luminex Corporation
Event
Event 94970
Status
Ongoing
Classification
Class II
Quantity
1,100 kits
Official record key
device-enforcement:Z-2533-2024

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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