Reported Sep 11, 2019 · Terminated
BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
Becton Dickinson & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212
Is this the product you have?
- BD Kiestra InoqulA Software Version 20.3.IVD automated
- specimen processing Catalog Number447202
- Lot codes and dates
- Catalog Number447202 Catalog Number/UDI
INO-00028700382904472023INO-00028600382904472023INO-00026900382904472023INO-00028100382904472023
- Catalog Number447202 Catalog Number/UDI
- Amount recalled
- 4 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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