Lower risk Medical device recall · FDA · Published September 14, 2018

Luminex VERIGENE Blood Culture Kits Recall: False Negative Risk

Luminex recalls VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (five-pack carriers) due to potential false negative results in bacterial detection tests. Affected units include specific supplier and utility tray lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0445-2019Medical device Luminex ›

Lower-risk recall

Potential to lead to a false negative results.

Take action

Contact the company

Recalling firmLuminex Corporation12212 Technology Blvd · Austin, TX 78727-6101

✎ GovInfoNow plain-language explainer

Luminex is recalling VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (five-pack carriers) because they may cause false negative results in bacterial detection tests. This could lead to incorrect diagnoses and treatment decisions if the kits are used without the recall fix. Read more at govinfonow.com/recall/69859-luminex-verigene-blood-culture-kits-recall-false-negative-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69859-luminex-verigene-blood-culture-kits-recall-false-negative-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0445-2019

Cite this page

“Luminex VERIGENE Blood Culture Kits Recall: False Negative Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69859-luminex-verigene-blood-culture-kits-recall-false-negative-risk. Based on FDA recall #Z-0445-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0445-2019%22&limit=1).

The FDA announced on Sept. 14, 2018, that Luminex Corporation voluntarily recalled VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits due to the potential for false negative results. The agency issued recall number Z-0445-2019 for the in vitro diagnostic test kits.

How to tell if you have it

Brand: Luminex
Product: VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers)
Supplier raw tray lots: 195916-070518 and 190943-073118
Utility Tray Lots: 082518018C, 081618018C, 082918018C, 090418018B, 081118018C and 082718018B
Quantity: 12,700 trays

The hazard

The kits may lead to false negative results. This defect affects the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.

Context

GovInfoNow's records show Luminex Corporation has 22 other recalls on record since May 8, 2018. Other recent recalls include a VERIGENE Gram Negative Blood Culture Test recall on April 16, 2025, for false negative risk, a Verigene Gram Positive Blood Culture Test recall on June 20, 2024, for false positive risk, and a VERIGENE BC-GP Utility Tray Recall on Nov. 7, 2023, for defective trays. Other recent recalls of similar products include the Biomerieux VITEK 2 AST-N461 Test Kit recall on July 24, 2026, for false resistant results risk, a BioFire Joint Infection Panel recall on April 22, 2026, for false positives risk, and a Biomerieux VITEK 2 AST-N447 Kit recall on June 4, 2026, for false resistance results risk.

How to tell if you have this one

Check for the product name 'VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits' packaged as five-pack carriers. Affected units include supplier raw tray lots 195916-070518, 190943-073118 and utility tray lots 082518018C, 081618018C, 082918018C, 090418018B, 081118018C, and 082718018B.

Brand
Luminex
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Numbers
Compare your kit's lot numbers with the listed affected lots: supplier raw tray lots 195916-070518 and 190943-073118, and utility tray lots 082518018C, 081618018C, 082918018C, 090418018B, 081118018C, and 082718018B.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 34 states.

FDA distribution: “Worldwide Distribution - US Nationwide in the states of United States - AZ, CA, CO, CT, DC, FL, GA,, IA, ID, IN, KA,, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NV, NJ, NY, OK,,OH, OR, PA, SC, TN, TX, UT, VT, WA, KS, and VA.. France” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Sep 14, 2018Firm started the recall
Nov 9, 2018FDA classified it Class II
Nov 21, 2018Published in FDA’s Enforcement Report
Apr 28, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are these kits safe to use?

The recall is due to potential false negative results, not immediate safety hazards. Kits with unaffected lot numbers should be safe for use.

Similar recalls

Latest medical device recalls

Keep exploring

More Luminex recalls

Link to this recall

<a href="https://govinfonow.com/recall/69859-luminex-verigene-blood-culture-kits-recall-false-negative-risk">Luminex VERIGENE Blood Culture Kits Recall: False Negative Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0445-2019 (September 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0445-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.