Becton Dickinson & Co.: BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

Is my product affected?

BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

• UPC 00382904472139

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Co. has recalled BD Kiestra InoqulA+ Software Version 20.3, an automated specimen processing system. An anomaly in this software version can cause a mismatch between a specimen and plate. Nine units with the affected catalog number 447213 were distributed across Illinois, Iowa, Missouri, New York, Ohio, Tennessee, and internationally to Singapore, Taiwan, France, and the Netherlands.

The recall notice does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate Distribution: Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands Quantity: 9 units Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• BD Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 4472022019-07-26
• HS70A Diagnostic Ultrasound System Version 2.01.00, 2.01.01, 2.01.02, 2.01.03, 2.01.04, 2.01.05, 2.01.06, 1.00.06, 1.00.07, 1.00.08, 1.00.09, 1.00.10, 1.00.11, 1.00.122019-07-25
• WS80A Diagnostic Ultrasound System Version 1.00.16, 3.00.17, 3.00.18, 3.00.19, 3.01.00, 3.01.01, 3.01.02, 3.01.03, 3.01.04, 3.01.05, 3.01.06, 3.01.07, 3.01.08, 3.01.09, 4.00.08, 4.00.09, 4.00.10, 4.00.11, 4.01.00, 4.01.01, 4.01.02, 4.01.03, 4.01.04, 4.01.05, 4.01.06, 4.01.07, 4.01.08, 4.01.09.2019-07-25
• Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:168-120,168-150,168-180,168-210,168-240,168-270,168-300,168-330,168-360,168-390,168-420,168-450,168-480,168-2019-07-24
• Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM-410320; Style LF: LF-41012019-07-24

All FDA (Device enforcement) recalls