BD Kiestra InoqulA Software Version 20.3.IVD Recalled for Specimen Mismatch Risk
Becton Dickinson & Co. is recalling 4 units of BD Kiestra InoqulA Software Version 20.3.IVD due to an anomaly that may cause specimen and plate mismatches.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Becton Dickinson & Co. is recalling 4 units of BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing (Catalog Number: 447202). The recall is due to an anomaly present in the software that has the potential to cause a mismatch between a specimen and a plate.
The affected units were distributed in Illinois, Iowa, Missouri, New York, Ohio, and Tennessee, as well as in Singapore, Taiwan, France, and the Netherlands. The specific catalog numbers and UDI codes associated with the recall are 447202, INO-000287 00382904472023, INO-000286 00382904472023, INO-000269 00382904472023, and INO-000281 00382904472023.
Users of this software should contact Becton Dickinson & Co. for further instructions on how to address the anomaly and ensure specimen integrity.
The recalled product
- Product
- BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 4
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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