CLASS II Device recall · Reported 22 May 2019 · FDA Enforcement Report

BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to recalled

Becton Dickinson & is recalling BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System, distributed nationwide in the US. The recall was initiated on 3 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled32 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1313-2019
FDA event ID: 82616
Recalling firm: Becton Dickinson &, Sparks, MD
Classification: Class II
Status: Terminated
Recall initiated: 3 Apr 2019
FDA classified: 10 May 2019
Reported: 22 May 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Test Kits & Diagnostics

Timeline

3 Apr 2019	Recall initiated by company
10 May 2019	Classified by FDA	+37 days
22 May 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066

Where it was distributed

Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan

Nationwide

Questions about this recall

Is BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System recalled?

Yes. Becton Dickinson & recalled BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System on 3 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1313-2019.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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