Recall – IVD specimen processor software error may cause mismatch

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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
Registration Link

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.