The Recall Desk
HighFDA (Devices)·Z-2439-2019·Announced 2019-09-11

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.

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) 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
Hazard
Affected units
9

Distribution

Distributed in 6 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Becton Dickinson & Co.

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Same hazard · specimen mismatch

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