Recall Z-2439-2019

Becton Dickinson & Co. · initiated July 26, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

Codes / lots: Catalog Number: 447213 Serial Number/UDI: INO-000290 00382904472139 INO-000263 00382904472139 INO-000264 00382904472139 20130276 00382904472139 INO-000282 00382904472139 INO-000284 00382904472139 INO-000272 00382904472139 INO-000274 00382904472139

Reason for recall

An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

FDA-determined cause: Software design

Action taken

BD initiated a field correction via letter on July 26, 2019 and BD Technical Service has completed the correction (software upgrade) for all six (6) affected US customers. Letter identifies issue, health risk and customer action to take. BD is in the process of evaluating the log files of customers using the InoqulATM / InoqulA+TM software version 20.3 to determine if any users potentially experienced mismatch between a specimen and plate. BD will contact all customers using InoqulATM / InoqulA+TM software version 20.3 to provide the outcome of this evaluation. Contact: 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.

Details

Recall number
Z-2439-2019
Initiated
July 26, 2019
Terminated
December 6, 2019
Product code
JTC – Device, Microtiter Diluting/Dispensing
Quantity
9 units
Distribution
Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Recalling firm
Becton Dickinson & Co., Sparks, MD

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2438-2019 Class IIBD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog…An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch… 07/26/2019Terminated