BD Kiestra InoqulA+ Software Version 20.3. IVD recall: Software Issue
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Why was BD Kiestra InoqulA+ Software Version 20.3. IVD recalled?
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 9 units
- Distribution
- Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
- Recall date
- September 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)