BD Kiestra InoqulA+ Software Version 20.3 Recalled for Specimen Mismatch Risk
Becton Dickinson & Co. is recalling 9 units of BD Kiestra InoqulA+ Software Version 20.3 due to an anomaly that may cause specimen and plate mismatches.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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) where a specimen mismatch could lead to incorrect diagnostic results, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling 9 units of BD Kiestra InoqulA+ Software Version 20.3, an in vitro diagnostic (IVD) automated specimen processing system. The recall is due to an anomaly 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 number is 447213.
Healthcare facilities and users of this software should stop using the affected version and contact Becton Dickinson & Co. for further instructions on remediation or replacement.
The recalled product
- Product
- BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — IVD Software
- Affected units
- 9
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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