FDA Medical Device Recalls (openFDA)
Becton Dickinson & Co.: BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
- Recall number
- Z-1313-2019
- 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
- Status
- Terminated
- Initiated
- 2019-04-03
- Posted
- not on file
- Terminated
- 2020-05-04
- Reason
- 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
- 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
- 32 units
- Distribution
- Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K180438"]
- PMA numbers
- not on file
- Product code
- PSZ
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28