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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82616

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 03, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Becton Dickinson & Co.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-1313-2019
Recall number
Z-1313-2019
Initiated
April 03, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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

device · product 2 of 2

BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055

Z-1314-2019
Recall number
Z-1314-2019
Initiated
April 03, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
124

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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

Code information

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

Distribution pattern

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