Date Initiated by Firm |
July 26, 2019 |
Create Date |
August 30, 2019 |
Recall Status1 |
Terminated 3 on December 06, 2019 |
Recall Number |
Z-2439-2019 |
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 : 447213 |
Code Information |
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 |
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 |
9 units |
Distribution |
Illinois, Iowa, Missouri, New York, Ohio, Tennessee
World Wide (5): Singapore, Taiwan, France, Netherlands |
Total Product Life Cycle |
TPLC Device Report
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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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