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U.S. Department of Health and Human Services

Class 2 Device Recall BD Kiestra InoqulA Software Version 20.3

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  Class 2 Device Recall BD Kiestra InoqulA Software Version 20.3 see related information
Date Initiated by Firm July 26, 2019
Create Date August 30, 2019
Recall Status1 Terminated 3 on December 06, 2019
Recall Number Z-2438-2019
Recall Event ID 83513
Product Classification Device, microtiter diluting/dispensing - Product Code JTC
Product BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing

Catalog Number: 447202
Code Information Catalog Number: 447202  Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023  
Recalling Firm/
Manufacturer		 Becton Dickinson & Co.
7 Loveton Cir
Sparks MD 21152-9212
Manufacturer 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 2		 Software design
Action 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.
Quantity in Commerce 4 units
Distribution Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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