FDA Enforcement
Class II
Terminated
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Recall: Z-0204-2020
·
Reported October 30, 2019
Enforcement
- Recall Number
- Z-0204-2020
- Event ID
- 83655
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 30, 2019
- Initiation Date
- August 15, 2019
- Classification Date
- October 24, 2019
- Termination Date
- May 5, 2022
- Address
- 511 Benedict Ave, Tarrytown, NY, 10591-5005, United States
Description
Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
Reason
Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2
Code Info
(SW) version V1.19.0 and V1.19.2 UDI: 00630414007960
Distribution
Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam
Quantity
88 total US: 54;OUS 34