Company: Becton Dickinson & Co.
Date of Enforcement Report: 9/11/2019
Class II
PRODUCT
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
- Recall Number: Z-2438-2019
- Recall Number: Z-2439-2019
REASON
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate.
RECALLING FIRM/MANUFACTURER
Becton Dickinson & Co. on 7/26/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
US Nationwide and International