FDAFDA · Food and drugs·Recall number Z-2439-2019
BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213
Published September 11, 2019 · Recall initiated: July 26, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands
- Lot
- Catalog Number: 447213 Serial Number/UDI: INO-000290 00382904472139 INO-000263 00382904472139 INO-000264 00382904472139 20130276 00382904472139 INO-000282 00382904472139 INO-000284 00382904472139 INO-000272 00382904472139 INO-000274 00382904472139
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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