The Recall Desk

FDA (Devices) recall action 83513

Becton Dickinson & Co. recalled 2 products on 2019-09-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-09-11
Critical
0
Units
13

Why these products were recalled

An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    Product
    BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
    Category
    Distribution
    6 states
  • HighFDA (Devices)··2019-09-11

    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.

    Product
    BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202
    Category
    Distribution
    6 states