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

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