Z-1313-2019Class II

BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices...

Name: Z-1313-2019 BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices...
Creator: Becton Dickinson & Co.
Published: 2019-04-03
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-04-03 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066 on 2019-04-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1313-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-03
Posted: 2019-05-10
Terminated: 2020-05-04
Recalling firm: Becton Dickinson & Co
Product: BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
Product code: PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: BD notified customers by letter on 4/3/19 via FedX providing problem, health risk and action to take: BD is requesting that customers discard the affected instrument(s) for replacement. BD will replace your affected Veritor instrument(s) upon receipt of the Customer Response Form. BD Customer/Technical Support 800-638-8663 Monday Friday between 7:00am and 7:00pm (EST) in the United States.For customers outside the US, contact your local BD representative or distributor.
Quantity in commerce: 32 units
Distribution: Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
Product codes and lots: 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 1702147J04360

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1313-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1313-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-10
Z-1314-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-22	2019-05-10

Product code PSZ

K180438Class IIBD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd / cleared 2018-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)