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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 FirmJuly 26, 2019
Create DateAugust 30, 2019
Recall Status1 Terminated 3 on December 06, 2019
Recall NumberZ-2439-2019
Recall Event ID 83513
Product Classification Device, microtiter diluting/dispensing - Product Code JTC
ProductBD 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
FEI Number 1119779
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
ActionBD 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 Commerce9 units
DistributionIllinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
Total Product Life CycleTPLC 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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