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Lower risk Medical device recall · FDA · Published April 3, 2019

BD Veritor System Reader Recall: False Test Results Risk Misdiagnosis

Becton Dickinson recalls BD Veritor System Reader (Catalog 256055) due to potential false test results causing misdiagnosis. Affected units have specific serial numbers listed.

🇺🇸 FDA recall #Z-1314-2019Medical deviceBecton Dickinson ›
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Recalling firmBecton Dickinson & Co.7 Loveton Cir · Sparks, MD 21152-9212
✎ GovInfoNow plain-language explainer

Becton Dickinson is recalling its BD Veritor System Reader to prevent false test results that could lead to misdiagnosis and inappropriate treatment. This affects specific units with listed serial numbers. Read more at govinfonow.com/recall/68497-bd-veritor-system-reader-recall-false-test-results-risk-misdiagnosis.

Source Summary by GovInfoNow · govinfonow.com/recall/68497-bd-veritor-system-reader-recall-false-test-results-risk-misdiagnosis · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1314-2019

Cite this page

“BD Veritor System Reader Recall: False Test Results Risk Misdiagnosis.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68497-bd-veritor-system-reader-recall-false-test-results-risk-misdiagnosis. Based on FDA recall #Z-1314-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1314-2019%22&limit=1).

Becton Dickinson & Co. recalled the BD Veritor System Reader on April 3, 2019, according to the FDA. The device may produce false positive or negative results due to background calibration issues. Owners should contact the company for a remedy.

How to tell if you have it

  • Brand: Becton Dickinson
  • Product: BD Veritor System Reader - In Vitro Diagnostic for use with BD Veritor System Test Kit Devices
  • Catalog Number: 256055
  • Units affected: 124

The hazard

Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment.

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 (Oct. 23, 2025), and Becton Dickinson & Co. - Product Catalog (Sept. 23, 2025). Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), HardyDisk AST Cefiderocol 30μg FDC30 (June 8, 2026), and Meridian Bioscience Revogene C. difficile Test Recall (Dec. 5, 2025).

How to tell if you have this one

Check if your BD Veritor System Reader has the catalog number 256055 and one of the listed serial numbers. The device is used with BD Veritor System Test Kits for in vitro diagnostics.

  • 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
    Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
Recall numberProduct, codes & lotsQuantity
Z-1313-2019BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066; Serial Numbers: Serial Number 1807138J1E050 1710067J160C0 1703027J07FD0 1810268J2D370 1710217J18470 1703027J084C0 1703307J0C630 1710067J16190 1709187J12360 1710267J19D40 1710067J16230 1710067J161D0 1710067J161F0 1710067J16260 1807138J1E0B0 1609076J04270 1802138J07B40 1803298J11070 1802078J05D80 1704067J0DA00 1612166J070C0 1710257J18F50 1802028J044C0 1703167J0B0B0 1612026J07010 1710067J16110 1802058J05210 1811128J2FF50 1710067J16200 1710067J16270 1710237J185C0 1702147J0436032 units
Z-1314-2019BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055; Serial Numbers: Serial Number 1801179131J10 1801179119J10 1801179139J10 1801179117J10 1801179110J10 1801179115J10 1801159055J10 1801179120J10 1801159036J10 1801179109J10 1801179095J10 1801179128J10 1801189173J10 1801189181J10 1801189108J10 1801189146J10 1801189140J10 1801189126J10 1801189184J10 1801189159J10 1801179092J10 1801179137J10 1612139044GR0 1801179121J10 1801179124J10 1801179148J10 16102993246N0 1801159030J10 1801189102J10 1801189132J10 1801189166J10 1801169045J10 1801169012J10 1801169057J10 1801169049J10 1801169003J10 1801179155J10 1801179142J10 1710169021HM0 16102993166N0 1801169001J10 1801179096J10 1801179111J10 1801189176J10 1801189177J10 1801189180J10 1801169005J10 1801179094J10 1801179175J10 1801179113J10 1801179125J10 1801189104J10 1801189073J10 1801189082J10 1801169018J10 1801179157J10 1801179162J10 1801179156J10 1801189158J10 1801179105J10 1801179133J10 17122792607S0 1801169048J10 1801189183J10 1801189170J10 1801169051J10 1801169058J10 1801189127J10 1801179141J10 1801189178J10 1801189152J10 1801179144J10 1801179145J10 1603209035660 17121990337S0 1801179149J10 1801179165J10 1801159017J10 1801189106J10 1801179153J10 1801179154J10 1801179112J10 1801179101J10 1801189107J10 1801189168J10 16083090396J0 16083090446J0 16083090476J0 16083090766J0 16083190426J0 16083190656J0 1801189169J10 1801039026J00 1801189135J10 16083190756J0 1801169060J10 1801169056J10 1801169004J10 1801179130J10 1801179098J10 1801179114J10 1801179136J10 1801179134J10 1801179122J10 1703259291H60 1801189116J10 1604209189G80 1801159029J10 1801189063J10 1801189072J10 1801169019J10 1801179147J10 1801189182J10 1801189174J10 1801169050J10 1801169052J10 1801169006J10 1801189151J10 1801189061J10 1801189090J10 1801189167J10 1801189160J10 1801159039J10 1801159047J10124
Based on the official FDA remedy

What to do — step by step

  1. Check Device Serial Number

    Verify your device's serial number against the list provided in the recall notice to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

1. Firm started the recall: Apr 3, 201912. FDA classified it Class II: May 10, 201923. Published in FDA’s Enforcement Report: May 22, 201934. FDA terminated the recall: May 4, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-1314-2019 (April 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1314-2019 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA