Z-1313-2019 Class II Terminated
FDA device recall Z-1313-2019 was initiated by Becton Dickinson & Co. on April 3, 2019 and is designated Class II. 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 inappropria… The recall status is terminated (terminated May 4, 2020). Affected quantity: 32 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- April 3, 2019
- Termination Date
- May 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 units
Product Description
BD Veritor Plus Analyzer- In-Vitro Diagnostic intended to use with the BD Veritor System Test Devices. Catalog Number: 256066
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
Distribution Pattern
Nationwide Foreign: Canada, Chile, Hong Kong, Japan, Taiwan
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