Lower risk Medical device recall · FDA · Published September 24, 2018

Becton Dickinson BD Max Instrument Recall: False Candida Glabrata Results

Becton Dickinson recalls BD Max instruments (catalog 441916-441927) due to false positive Candida glabrata results when Trichomonas vaginalis is present. Affected units have serial numbers CTI1201-CTI1288.

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

🇺🇸 FDA recall #Z-0313-2019Medical device Becton Dickinson ›

Lower-risk recall

A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.

Take action

Contact the company

Recalling firmBecton Dickinson & Co.7 Loveton Cir, BD Diagnostic Systems · Sparks, MD 21152-9212

✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling refurbished BD Max instruments with catalog numbers 441916-441927 because they can give false positive Candida glabrata results when a Trichomonas vaginalis test is also positive. This could lead to incorrect diagnoses and treatment decisions. Read more at govinfonow.com/recall/69819-becton-dickinson-bd-max-instrument-recall-false-candida-glabrata-results.

Source Summary by GovInfoNow · govinfonow.com/recall/69819-becton-dickinson-bd-max-instrument-recall-false-candida-glabrata-results · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0313-2019

Cite this page

“Becton Dickinson BD Max Instrument Recall: False Candida Glabrata Results.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69819-becton-dickinson-bd-max-instrument-recall-false-candida-glabrata-results. Based on FDA recall #Z-0313-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0313-2019%22&limit=1).

Becton Dickinson & Co. recalled BD Max Instruments, catalog numbers 441916 and 441927, due to false positive Candida glabrata results, the FDA said on Sept. 24, 2018. The agency announced the voluntary Class II recall of 49 refurbished units distributed worldwide.

How to tell if you have it

Brand: Becton Dickinson
Product: BD Max Instrument (refurbished)
Catalog Numbers: 441916, 441927
Serial Numbers: CTI1201-CTI1288

The hazard

A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.

Context

GovInfoNow's records show Becton Dickinson & Co. has 43 other recalls on record since June 1, 2017. Other recent recalls of similar products include BD GasP: CO2 Pouch System Recall (April 7, 2026), BD Kiestra Isolate Suspension Cuvette Array Recall (Oct. 23, 2025), and BD MAX System Recall (Sept. 23, 2025). Other recent recalls of similar products include Becton Dickinson Spinal Tray Recall (April 27, 2026), Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025), and HardyDisk AST Cefiderocol 30μg FDC30 Recall (June 8, 2026).

How to tell if you have this one

Check for catalog numbers 441916 or 441927 on the instrument. Affected units have serial numbers from CTI1201 to CTI1288. These are refurbished instruments used in clinical labs.

Brand
Becton Dickinson
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. Countries of Spain, Germany, France, Austria, Denmark, Switzerland, Sweden, Italy, Kuwait, Oman, Saudi Arabia, and Turkey.

Recall number	Product, codes & lots	Quantity
Z-0312-2019	BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.; Serial Numbers: 079577 to 079896, 78154, 78503, 78363, 78321, 78584, 78840, 78975, 78711, 77048, 79783, 78857, 79162, 78387, 78182, 78832, 78905, 77062, 78856, 78352, 78903, 78667, 78665, 78928, 78986, 77108, 77543, 78615, 78481, 77373, 77707, 78927	23
Z-0313-2019	BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.; Serial Numbers: CTI1201-CTI1288	49

Based on the official FDA remedy

What to do — step by step

Check Instrument Details
Identify the catalog number and serial number on your BD Max instrument to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 27 states.

FDA distribution: “Worldwide distribution - US nationwide in the states of AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico. Countries of Spain, Germany, France, Austria, Denmark,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, Missouri, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Sep 24, 2018Firm started the recall
Oct 31, 2018FDA classified it Class II
Nov 7, 2018Published in FDA’s Enforcement Report
Apr 10, 2020FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/69819-becton-dickinson-bd-max-instrument-recall-false-candida-glabrata-results">Becton Dickinson BD Max Instrument Recall: False Candida Glabrata Results (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-0313-2019 (September 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0313-2019 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.