BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices
Medical device recall Z-1314-2019. Published in FDA’s Enforcement Report on May 22, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 22, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 124 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055
124, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: Serial Number 1801179131J10 1801179119J10 1801179139J10 1801179117J10 1801179110J10 1801179115J10 1801159055J10 1801179120J10 1801159036J10 1801179109J10 1801179095J10 1801179128J10 1801189173J10 1801189181J10 1801189108J10…
Every code shown here, 1,765 characters
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 1801159047J10
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 3, 2019.
- FDA classified it on May 10, 2019.
- FDA’s Enforcement Report published it on May 22, 2019.
- FDA terminated it on May 4, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Becton Dickinson & Co., of Sparks, MD.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.